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High Dose Trial in COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BEA 2180 BR
tiotropium
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Trough forced expiratory volume (FEV1) response
forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.

Secondary Outcome Measures

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

Full Information

First Posted
August 9, 2005
Last Updated
October 28, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00128440
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BEA 2180 BR
Intervention Type
Drug
Intervention Name(s)
tiotropium
Primary Outcome Measure Information:
Title
Trough forced expiratory volume (FEV1) response
Time Frame
baseline to 24 hours post drug administration
Title
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
Secondary Outcome Measure Information:
Title
Trough FVC response after 4 weeks
Time Frame
after 4 weeks
Title
FEV1 and FVC peak response after 0 and 4 weeks
Time Frame
after 0 and 4 weeks
Title
FVC AUC0-6h after 0 and 4 weeks
Time Frame
after 0 and 4 weeks
Title
Individual FEV1 and FVC measurements at each time point
Time Frame
4 weeks
Title
Weekly mean pre-dose morning and evening PEFR
Time Frame
4 weeks
Title
Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]
Time Frame
4 weeks
Title
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest
Time Frame
4 weeks
Title
Physician's Global Evaluation
Time Frame
4 weeks
Title
All adverse events
Time Frame
28 weeks
Title
Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing
Time Frame
28 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Lakewood
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Pembroke Farms
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Larchmont
State/Province
New York
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Harker Heights
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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High Dose Trial in COPD

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