Clinical Trials/NCT00528996

NCT00528996

Completed

Phase 2

A Multinational, Randomised, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim178 sites in 1 country2,080 target enrollmentSeptember 6, 2007

ConditionsPulmonary Disease, Chronic Obstructive

InterventionsPlacebo BEA 2180 BR Tiotropium Bromide

DrugsBEA 2180 BR Tiotropium Bromide Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 2080
Locations: 178
Primary Endpoint: Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.

Registry

clinicaltrials.gov

Start Date

September 6, 2007

End Date

May 5, 2009

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
•All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:
•Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) \<80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
•Male or female patients 40 years of age or older.
•Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
•Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
•Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)

Exclusion Criteria

•Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
•Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No.
•Patients with a recent history (one year or less) of myocardial infarction.
•Patients with any unstable or life-threatening cardiac arrhythmia.
•Patients who have been hospitalized for heart failure within the past 3 years.
•Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
•Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No.
•Patients with known narrow-angle glaucoma.
•Patients with asthma or a history of asthma.
•Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.

Arms & Interventions

Placebo

Matching Placebo

Intervention: Placebo

BEA 2180 BR low dose

Low dose

Intervention: BEA 2180 BR

BEA 2180 BR medium dose

Medium dose

Intervention: BEA 2180 BR

BEA 2180 BR high dose

High dose

Intervention: BEA 2180 BR

Tiotropium Bromide

Intervention: Tiotropium Bromide

Outcomes

Primary Outcomes

Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks

Time Frame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24.

Trough Forced expiratory volume in one second (FEV1) response was defined as the change from baseline in trough FEV1. Trough FEV1 was defined as the mean of the two FEV1 measurements recorded at the pre-dose measurements (40 and 15 minutes before the drug administration) at the end of the dosing interval (24 hours post previous drug administration from the Respimat® Inhaler). Baseline FEV1 was pre-treatment FEV1 values measured at Day 1 of treatment period (baseline) prior to administration of the first dose of study medication, which was the mean of the measurements recorded from the pulmonary function tests taken at 40 and 15 minutes prior to drug administration at Day 1 of treatment period.

Secondary Outcomes

Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks(40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12, 18, and 24.)
Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks(40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.)
Weekly Mean Evening Peak Expiratory Flow Rate (PEFR)(Assessed at bed time per day during 24 weeks with weekly mean values reporting.)
Transition Dyspnea Index - Functional Impairment Domain Score(At Week 0 (baseline), 4, 12 and 24.)
St. George's Respiratory Questionnaire (SGRQ) Total Score(At Week 0, 4, 12, and 24.)
36-item-health Survey (SF-36) - Vitality Domain Score(At Week 4, 12, and 24.)
Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks(40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12 and 18.)
Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5(40 minutes (min) and 15 min before drug administration at Day 1 (baseline) and Day 3 and 5 of treatment period.)
Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration(3 minutes (min) and 10 after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.)
Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration(3 minutes (min) and 10 min after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.)
36-item-health Survey (SF-36) - Physical Function Domain Score(At Week 4, 12, and 24.)
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks(40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.)
Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point(15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.)
Individual Forced Vital Capacity (FVC) Measurements at Each Time Point(15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.)
Transition Dyspnea Index - Magnitude of Effort Domain Score(At Week 0 (baseline), 4, 12 and 24)
36-item-health Survey (SF-36) 8 Domain Scores at Baseline(At baseline (Week 0, Day 1 of treatment period).)
36-item-health Survey (SF-36) - General Physical Health Domain Score(At Week 4, 12, and 24.)
Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks(40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.)
Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks(40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.)
Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR)(Assessed before drug administration per day during 24 weeks with weekly mean values reporting.)
Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol])(Assessed once per day during 24 weeks with weekly mean values reporting.)
Physician's Global Evaluation(At Week 0, 4, 12, and 24.)
Transition Dyspnea Index - Magnitude of Task Domain Score(At week 0 (baseline), 4, 12 and 24)
36-item-health Survey (SF-36) - Role Physical Domain Score(At Week 4, 12, and 24.)
36-item-health Survey (SF-36) - Bodily Pain Domain Score(At Week 4, 12, and 24.)
36-item-health Survey (SF-36) - Social Functioning Domain Score(At Week 4, 12, and 24.)
36-item-health Survey (SF-36) - General Mental Health Domain Score(At Week 4, 12, and 24.)
36-item-health Survey (SF-36) - Role Emotional Domain Score(At Week 4, 12, and 24.)
Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation(From first does until 30 days after the end of treatment, up to 205 days.)
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation(From first does until 30 days after the end of treatment, up to 205 days.)