High Dose Trial in COPD

October 28, 2013 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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).
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.
Male or female patients 40 years of age or older.
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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Trough forced expiratory volume (FEV1) response Time Frame: baseline to 24 hours post drug administration	baseline to 24 hours post drug administration
forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment. Time Frame: after 4 weeks	after 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Individual FEV1 and FVC measurements at each time point Time Frame: 4 weeks	4 weeks
Weekly mean pre-dose morning and evening PEFR Time Frame: 4 weeks	4 weeks
Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] Time Frame: 4 weeks	4 weeks
Physician's Global Evaluation Time Frame: 4 weeks	4 weeks
Trough FVC response after 4 weeks Time Frame: after 4 weeks	after 4 weeks
FEV1 and FVC peak response after 0 and 4 weeks Time Frame: after 0 and 4 weeks	after 0 and 4 weeks
FVC AUC0-6h after 0 and 4 weeks Time Frame: after 0 and 4 weeks	after 0 and 4 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest Time Frame: 4 weeks	4 weeks
All adverse events Time Frame: 28 weeks	28 weeks
Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing Time Frame: 28 weeks	28 weeks
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) Time Frame: 28 weeks	28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

Boehringer Ingelheim Study Coordinator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 9, 2005

First Submitted That Met QC Criteria