MedPath

Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

Phase 4
Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Drug: Placebo
Registration Number
NCT00523991
Lead Sponsor
Boehringer Ingelheim
Brief Summary

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
457
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
placeboPlaceboOral inhalation once daily of placebo matching tiotropium via handihaler
tiotropiumtiotropiumOral inhalation once daily of 18mcg tiotropium via handihaler
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)baseline, week 24

Change = Week 24 Value - Baseline Value

Secondary Outcome Measures
NameTimeMethod
Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)Baseline

Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)Baseline, week 8

Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)Baseline, week 16

Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)Baseline, week 24

Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

Peak Forced Expiratory Volume in 1 Second (Baseline)Baseline

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)Baseline, week 8

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)Baseline, week 16

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)Baseline, week 24

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)Baseline

Forced expiratory volume in 1 second (baseline, pre-dose)

Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)baseline, 30 minutes

Forced expiratory volume in 1 second (baseline, 30 minutes)

Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)baseline, 60 minutes

Forced expiratory volume in 1 second (baseline, 60 minutes)

Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)Baseline, 120 minutes

Forced expiratory volume in 1 second (baseline, 120 minutes)

Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)Baseline, 180 minutes

Forced expiratory volume in 1 second (baseline, 180 minutes)

Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)baseline, week 8, pre-dose

Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)

Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)Baseline, week 8, 30 minutes

Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)

Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)baseline, week 8, 60 minutes

Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)

Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)baseline, week 8, 120 minutes

Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)

Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)baseline, week 8, 180 minutes

Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)

Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)baseline, week 16, pre-dose

Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)Baseline, week 16, 30 minutes

Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)baseline, week 16, 60 minutes

Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)baseline, week 16, 120 minutes

Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)baseline, week 16, 180 minutes

Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)baseline, week 24, pre-dose

Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)baseline, week 24, 30 minutes

Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)baseline, week 24, 60 minutes

Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)baseline, week 24, 120 minutes

Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)baseline, week 24, 180 minutes

Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)

FVC AUC0-3 at Baselinebaseline

Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)

FVC AUC0-3 at Week 8 Minus Baselinebaseline, week 8

Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)

FVC AUC0-3 at Week 16 Minus Baselinebaseline, week 16

Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)

FVC AUC0-3 at Week 24 Minus Baselinebaseline, week 24

Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)

Trough Forced Vital Capacity (Baseline)baseline

Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

Change From Baseline in Trough Forced Vital Capacity (at Week 8)baseline, week 8

Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

Change From Baseline in Trough Forced Vital Capacity (at Week 16)baseline, week 16

Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

Change From Baseline in Trough Forced Vital Capacity (at Week 24)baseline, week 24

Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

Peak Forced Vital Capacity (FVC) (Baseline)baseline

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.

Change From Baseline in Peak Forced Vital Capacity (at Week 8)baseline, week 8

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

Change From Baseline in Peak Forced Vital Capacity (at Week 16)baseline, week 16

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

Change From Baseline in Peak Forced Vital Capacity (at Week 24)baseline, week 24

Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

Forced Vital Capacity (Baseline, Pre-dose)baseline

Forced vital capacity (baseline, pre-dose)

Forced Vital Capacity (Baseline, 30 Minutes)baseline, 30 minutes

Forced vital capacity (baseline, 30 minutes)

Forced Vital Capacity (Baseline, 60 Minutes)baseline, 60 minutes

Forced vital capacity (baseline, 60 minutes)

Forced Vital Capacity (Baseline, 120 Minutes)baseline, 120 minutes

Forced vital capacity (baseline, 120 minutes)

Forced Vital Capacity (Baseline, 180 Minutes)baseline, 180 minutes

Forced vital capacity (baseline, 180 minutes)

Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)baseline, week 8, pre-dose

Change from baseline in forced vital capacity (week 8, pre-dose)

Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)baseline, week 8, 30 minutes

Change from baseline in forced vital capacity (week 8, 30 minutes)

Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)baseline, week 8, 60 minutes

Change from baseline in forced vital capacity (week 8, 60 minutes)

Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)baseline, week 8, 120 minutes

Change from baseline in forced vital capacity (week 8, 120 minutes)

Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)baseline, week 8, 180 minutes

Change from baseline in forced vital capacity (week 8, 180 minutes)

Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)baseline, week 16, pre-dose

Change from baseline in forced vital capacity (week 16, pre-dose)

Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)baseline, week 16, 30 minutes

Change from baseline in forced vital capacity (week 16, 30 minutes)

Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)baseline, week 16, 60 minutes

Change from baseline in forced vital capacity (week 16, 60 minutes)

Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)baseline, week 16, 120 minutes

Change from baseline in forced vital capacity (week 16, 120 minutes)

Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)baseline, week 16, 180 minutes

Change from baseline in forced vital capacity (week 16, 180 minutes)

Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)baseline, week 24, pre-dose

Change from baseline in forced vital capacity (week 24, pre-dose)

Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)baseline, week 24, 30 minutes

Change from baseline in forced vital capacity (week 24, 30 minutes)

Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)baseline, week 24, 60 minutes

Change from baseline in forced vital capacity (week 24, 60 minutes)

Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)baseline, week 24, 120 minutes

Change from baseline in forced vital capacity (week 24, 120 minutes)

Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)baseline, week 24, 180 minutes

Change from baseline in forced vital capacity (week 24, 180 minutes)

Albuterol Use p.r.n. (Baseline)baseline

Number of days that participants used albuterol prn per week

Change From Baseline in Albuterol Use p.r.n. - (Week 4)baseline, week 4

Difference in number of days that participants used albuterol prn per week between week 4 and baseline

Change From Baseline in Albuterol Use p.r.n. - (Week 8)baseline, week 8

Difference in number of days that participants used albuterol prn per week between week 8 and baseline

Change From Baseline in Albuterol Use p.r.n. -(Week 12)baseline, week 12

Difference in number of days that participants used albuterol prn per week between week 12 and baseline

Change From Baseline in Albuterol Use p.r.n. - (Week 16)baseline, week 16

Difference in number of days that participants used albuterol prn per week between week 16 and baseline

Change From Baseline in Albuterol Use p.r.n. -(Week 20)baseline, week 20

Difference in number of days that participants used albuterol prn per week between week 20 and baseline

Change From Baseline in Albuterol Use p.r.n. - (Week 24)baseline, week 24

Difference in number of days that participants used albuterol prn per week between week 24 and baseline

Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)baseline

The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)week 12

The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)week 24

The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)baseline

The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)week 12

The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)week 24

The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)baseline

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)baseline, week 4

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)baseline, week 8

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)baseline, week 12

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)baseline, week 16

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)baseline, week 20

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)baseline, week 24

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Healthbaseline

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)baseline, week 4

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)baseline, week 8

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)baseline, week 12

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)baseline, week 16

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)baseline, week 20

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)baseline, week 24

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)baseline

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)baseline, week 20

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 4

Moderate or higher intensity is greater than or equal to three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)baseline, week 24

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)baseline

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)baseline, week 4

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)baseline, week 8

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)baseline, week 12

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)baseline, week 4

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)baseline, week 8

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)baseline, week 16

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)baseline, week 20

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)baseline, week 24

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Daybaseline

Light intensity is less than three metabolic equivalents.

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)baseline, week 12

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)baseline, week 16

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 4

Light intensity is less than three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 8

Light intensity is less than three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 12

Light intensity defined as less than three metabolic equivalents.

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 16

Light intensity is less than three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 20

Light intensity is less than three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 24

Light intensity is less than three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Daybaseline

Moderate or higher intensity is greater than or equal to three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Active Energy Expenditure (Week 4)baseline, week 4

The amount of energy (kcal/day) that a person uses while physically active.

Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 8

Moderate or higher intensity is greater than or equal to three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 12

Moderate or higher intensity is greater than or equal to three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 16

Moderate or higher intensity is greater than or equal to three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 24

Moderate or higher intensity is greater than or equal to three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Number of Participants With Healthy Lifestyle (Week 4)week 4

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Number of Participants With Healthy Lifestyle (Baseline)baseline

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Active Energy Expenditure (Baseline)baseline

The amount of energy (kcal/day) that a person uses while physically active.

Change From Baseline in Active Energy Expenditure (Week 8)baseline, week 8

The amount of energy (kcal/day) that a person uses while physically active.

Change From Baseline in Active Energy Expenditure (Week 12)baseline, week 12

The amount of energy (kcal/day) that a person uses while physically active.

Change From Baseline in Active Energy Expenditure (Week 16)baseline, week 16

The amount of energy (kcal/day) that a person uses while physically active.

Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Daybaseline, week 20

Moderate or higher intensity is greater than or equal to three metabolic equivalents

Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

ln in measure value unit means natural logarithm

Number of Participants With Healthy Lifestyle (Week 8)week 8

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Change From Baseline in Active Energy Expenditure (Week 20)baseline, week 20

The amount of energy (kcal/day) that a person uses while physically active.

Change From Baseline in Active Energy Expenditure (Week 24)baseline, week 24

The amount of energy (kcal/day) that a person uses while physically active.

Number of Steps Per Day (Baseline)baseline

Number of steps per day (baseline)

Number of Participants With Healthy Lifestyle (Week 12)week 12

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Number of Participants With Healthy Lifestyle (Week 16)week 16

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Number of Participants With Healthy Lifestyle (Week 20)week 20

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Change From Baseline in Number of Steps Per Day (Week 24)baseline, week 24

Change from baseline in number of steps per day (week 24)

Number of Participants With Healthy Lifestyle (Week 24)week 24

Healthy lifestyle defined as 30 minutes of activity \> 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

Change From Baseline in Number of Steps Per Day (Week 4)baseline, week 4

Change from baseline in number of steps per day (week 4)

Change From Baseline in Number of Steps Per Day(Week 8)baseline, week 8

Change from baseline in number of steps per day (week 8)

Change From Baseline in Number of Steps Per Day (Week 12)baseline, week 12

Change from baseline in Number of steps per day (week 12)

Change From Baseline in Number of Steps Per Day (Week 16)baseline, week 16

Change from baseline in number of steps per day (week 16)

Change From Baseline in Number of Steps Per Day (Week 20)baseline, week 20

Change from baseline in number of steps per day (week 20)

Trial Locations

Locations (62)

205.365.1025 Boehringer Ingelheim Investigational Site

🇵🇹

Amadora, Portugal

205.365.1107 Boehringer Ingelheim Investigational Site

🇨🇿

Hradec Kralove, Czech Republic

205.365.1079 Boehringer Ingelheim Investigational Site

🇨🇿

Neratovice, Czech Republic

205.365.1116 Boehringer Ingelheim Investigational Site

🇨🇿

Pardubice, Czech Republic

205.365.1117 Boehringer Ingelheim Investigational Site

🇨🇿

Praha 6, Czech Republic

205.365.1022 Boehringer Ingelheim Investigational Site

🇵🇹

Lisboa, Portugal

205.365.1077 Boehringer Ingelheim Investigational Site

🇨🇿

Liberec, Czech Republic

205.365.1020 Boehringer Ingelheim Investigational Site

🇵🇹

Coimbra, Portugal

205.365.44002 Boehringer Ingelheim Investigational Site

🇬🇧

Garston, Watford, United Kingdom

205.365.44004 Boehringer Ingelheim Investigational Site

🇬🇧

Warminster, United Kingdom

205.365.1003 Boehringer Ingelheim Investigational Site

🇺🇸

Birmingham, Alabama, United States

205.365.1006 Boehringer Ingelheim Investigational Site

🇺🇸

Rochester, Minnesota, United States

205.365.1010 Boehringer Ingelheim Investigational Site

🇺🇸

Albuquerque, New Mexico, United States

205.365.1080 Boehringer Ingelheim Investigational Site

🇺🇸

Charlotte, North Carolina, United States

205.365.1103 Boehringer Ingelheim Investigational Site

🇧🇪

Gilly, Belgium

205.365.1057 Boehringer Ingelheim Investigational Site

🇧🇪

Menen, Belgium

205.365.1041 Boehringer Ingelheim Investigational Site

🇨🇦

Ste-Foy, Quebec, Canada

205.365.1122 Boehringer Ingelheim Investigational Site

🇺🇸

Clarksburg, West Virginia, United States

205.365.1058 Boehringer Ingelheim Investigational Site

🇧🇪

Yvoir, Belgium

205.365.1042 Boehringer Ingelheim Investigational Site

🇨🇦

Vancouver, British Columbia, Canada

205.365.1104 Boehringer Ingelheim Investigational Site

🇨🇦

Toronto, Ontario, Canada

205.365.1064 Boehringer Ingelheim Investigational Site

🇨🇿

Cvikov, Czech Republic

205.365.1083 Boehringer Ingelheim Investigational Site

🇨🇿

Praha 3, Czech Republic

205.365.1062 Boehringer Ingelheim Investigational Site

🇨🇿

Praha 10, Czech Republic

205.365.1066 Boehringer Ingelheim Investigational Site

🇩🇪

Berlin, Germany

205.365.1050 Boehringer Ingelheim Investigational Site

🇩🇪

Ulm, Germany

205.365.1072 Boehringer Ingelheim Investigational Site

🇳🇱

Etten Leur, Netherlands

205.365.1112 Boehringer Ingelheim Investigational Site

🇺🇦

Kharkov, Ukraine

205.365.1115 Boehringer Ingelheim Investigational Site

🇺🇦

Kiev, Ukraine

205.365.1113 Boehringer Ingelheim Investigational Site

🇺🇦

Simferopol, Ukraine

205.365.1052 Boehringer Ingelheim Investigational Site

🇩🇪

Rüdersdorf, Germany

205.365.1055 Boehringer Ingelheim Investigational Site

🇩🇪

Berlin, Germany

205.365.1004 Boehringer Ingelheim Investigational Site

🇺🇸

Birmingham, Alabama, United States

205.365.1098 Boehringer Ingelheim Investigational Site

🇺🇸

Jasper, Alabama, United States

205.365.1023 Boehringer Ingelheim Investigational Site

🇺🇸

Palo Alto, California, United States

205.365.1012 Boehringer Ingelheim Investigational Site

🇺🇸

Baltimore, Maryland, United States

205.365.1086 Boehringer Ingelheim Investigational Site

🇺🇸

Bloomington, Minnesota, United States

205.365.1033 Boehringer Ingelheim Investigational Site

🇺🇸

Pittsburgh, Pennsylvania, United States

205.365.1059 Boehringer Ingelheim Investigational Site

🇧🇪

Leuven, Belgium

205.365.1061 Boehringer Ingelheim Investigational Site

🇨🇿

Karlovy Vary, Czech Republic

205.365.1075 Boehringer Ingelheim Investigational Site

🇨🇿

Strakonice, Czech Republic

205.365.1063 Boehringer Ingelheim Investigational Site

🇨🇿

Tabor, Czech Republic

205.365.1067 Boehringer Ingelheim Investigational Site

🇬🇷

Athens, Greece

205.365.1076 Boehringer Ingelheim Investigational Site

🇨🇿

Usti nad Labem, Czech Republic

205.365.1054 Boehringer Ingelheim Investigational Site

🇩🇪

Gelnhausen, Germany

205.365.1126 Boehringer Ingelheim Investigational Site

🇬🇷

Thessaloniki, Greece

205.365.1127 Boehringer Ingelheim Investigational Site

🇬🇷

Athens, Greece

205.365.1070 Boehringer Ingelheim Investigational Site

🇳🇱

Enschede, Netherlands

205.365.1071 Boehringer Ingelheim Investigational Site

🇳🇱

Spijkenisse, Netherlands

205.365.1069 Boehringer Ingelheim Investigational Site

🇳🇱

Zutphen, Netherlands

205.365.1110 Boehringer Ingelheim Investigational Site

🇺🇦

Kharkiv, Ukraine

205.365.1128 Boehringer Ingelheim Investigational Site

🇺🇦

Dnipropetrovsk, Ukraine

205.365.44003 Boehringer Ingelheim Investigational Site

🇬🇧

Harrow, United Kingdom

205.365.1114 Boehringer Ingelheim Investigational Site

🇺🇦

Kiev, Ukraine

205.365.1007 Boehringer Ingelheim Investigational Site

🇺🇸

Rochester, New York, United States

205.365.1092 Boehringer Ingelheim Investigational Site

🇺🇸

Kingsport, Tennessee, United States

205.365.1056 Boehringer Ingelheim Investigational Site

🇨🇦

Kingston, Ontario, Canada

205.365.1125 Boehringer Ingelheim Investigational Site

🇺🇸

San Diego, California, United States

205.365.1024 Boehringer Ingelheim Investigational Site

🇺🇸

Lexington, Kentucky, United States

205.365.1108 Boehringer Ingelheim Investigational Site

🇺🇦

Kharkov, Ukraine

205.365.1085 Boehringer Ingelheim Investigational Site

🇺🇸

Omaha, Nebraska, United States

205.365.1118 Boehringer Ingelheim Investigational Site

🇺🇸

Cincinnati, Ohio, United States

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