High Dose Trial in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128440
• Other study ID #: 1205.6
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2005
• Last updated: October 28, 2013
• Start date: August 2005

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 84 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BEA 2180 BR

• tiotropium

Locations

Country	Name	City	State
United States	Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	Boehringer Ingelheim Investigational Site	Coeur d'Alene	Idaho
United States	Boehringer Ingelheim Investigational Site	Harker Heights	Texas
United States	Boehringer Ingelheim Investigational Site	Houston	Texas
United States	Boehringer Ingelheim Investigational Site	Lakewood	California
United States	Boehringer Ingelheim Investigational Site	Larchmont	New York
United States	Boehringer Ingelheim Investigational Site	Pembroke Farms	Florida
United States	Boehringer Ingelheim Investigational Site	Reno	Nevada
United States	Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	Boehringer Ingelheim Investigational Site	Wheat Ridge	Colorado
United States	Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough forced expiratory volume (FEV1) response		baseline to 24 hours post drug administration	No
Primary	forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.		after 4 weeks	No
Secondary	Trough FVC response after 4 weeks		after 4 weeks	No
Secondary	FEV1 and FVC peak response after 0 and 4 weeks		after 0 and 4 weeks	No
Secondary	FVC AUC0-6h after 0 and 4 weeks		after 0 and 4 weeks	No
Secondary	Individual FEV1 and FVC measurements at each time point		4 weeks	No
Secondary	Weekly mean pre-dose morning and evening PEFR		4 weeks	No
Secondary	Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]		4 weeks	No
Secondary	COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest		4 weeks	No
Secondary	Physician's Global Evaluation		4 weeks	No
Secondary	All adverse events		28 weeks	No
Secondary	Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing		28 weeks	No
Secondary	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)		28 weeks	No