Clinical trial NCT00128440: High Dose Trial in COPD
Official title: A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 μg and 400 μg of BEA 2180 BR to Tiotropium 5 μg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-08-10
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.


Eligibility criteria: 1. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 \>=30% and \<= 60% of predicted normal and FEV1 \<=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
2. All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
3. Male or female patients 40 years of age or older.
4. Smoker or ex-smoker with a history of more than 10 pack years.

1. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.

Primary outcomes:
measure: Trough forced expiratory volume (FEV1) response
timeFrame: baseline to 24 hours post drug administration
measure: forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.
timeFrame: after 4 weeks
Secondary outcomes:
measure: Trough FVC response after 4 weeks
timeFrame: after 4 weeks
measure: FEV1 and FVC peak response after 0 and 4 weeks
timeFrame: after 0 and 4 weeks
measure: FVC AUC0-6h after 0 and 4 weeks
timeFrame: after 0 and 4 weeks
measure: Individual FEV1 and FVC measurements at each time point
timeFrame: 4 weeks
measure: Weekly mean pre-dose morning and evening PEFR
timeFrame: 4 weeks
measure: Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]
timeFrame: 4 weeks
measure: COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest
timeFrame: 4 weeks
measure: Physician's Global Evaluation
timeFrame: 4 weeks
measure: All adverse events
timeFrame: 28 weeks
measure: Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing
timeFrame: 28 weeks
measure: 12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9)
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: Pembroke Farms
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Idaho
city: Reno
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Nevada
city: Larchmont
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Boehringer Ingelheim Investigational Site
state: North Carolina
city: Charleston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Harker Heights
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Richmond
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Washington
Study officials:
name: Boehringer Ingelheim Study Coordinator
References: