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

Phase 4

Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Drug: Placebo
Drug: tiotropium

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

Group	Intervention	Description
placebo	Placebo	Oral inhalation once daily of placebo matching tiotropium via handihaler
tiotropium	tiotropium	Oral inhalation once daily of 18mcg tiotropium via handihaler

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 Baseline	baseline	Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)
FVC AUC0-3 at Week 8 Minus Baseline	baseline, 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 Baseline	baseline, 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 Baseline	baseline, 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 Health	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 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 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 Day	baseline	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 Day	baseline, 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 Day	baseline, 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 Day	baseline, 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 Day	baseline, 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 Day	baseline, 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 Day	baseline, 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 Day	baseline	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 4) in Logarithm of Average Time Spent in Minutes Per Day	baseline, 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 Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day	baseline, 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 Day	baseline, 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 Day	baseline, 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 Day	baseline, 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 4)	baseline, week 4	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 Day	baseline, 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
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)
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)

Trial Locations

Locations (62): 205.365.1003 Boehringer Ingelheim Investigational Site
🇺🇸
Birmingham, Alabama, United States
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
205.365.1125 Boehringer Ingelheim Investigational Site
🇺🇸
San Diego, California, United States
205.365.1024 Boehringer Ingelheim Investigational Site
🇺🇸
Lexington, Kentucky, United States
205.365.1012 Boehringer Ingelheim Investigational Site
🇺🇸
Baltimore, Maryland, United States
205.365.1086 Boehringer Ingelheim Investigational Site
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Bloomington, Minnesota, United States
205.365.1006 Boehringer Ingelheim Investigational Site
🇺🇸
Rochester, Minnesota, United States
205.365.1085 Boehringer Ingelheim Investigational Site
🇺🇸
Omaha, Nebraska, United States
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205.365.1003 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States