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Dose Finding Study in COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
International
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 - 83 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

  • UAB Lung Health Center
  • Vapahcs 111P
  • Boehringer Ingelheim Investigational Site
  • GLAHS Sepulveda
  • Rehabilitation Clinical Trial Center
  • Boehringer Ingelheim Investigational Site
  • Hospital for Special Care
  • Bay Pines VA Medical Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • LSUHSC - Shreveport
  • VAMC-Reno
  • North Shore Universtiy Hospital
  • SVMMC
  • Boehringer Ingelheim Investigational Site
  • Hershey Medical Center
  • Boehringer Ingelheim Investigational Site
  • Frank Sciurba
  • Boehringer Ingelheim Investigational Site
  • MUSC
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • MEDVAMC
  • McGuire VA
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • CHU du Sart Tilman (B35)
  • A.Z. VUB
  • UZ Antwerpen
  • AZ Jan Palfijn
  • UZ Gent
  • Virga Jesseziekenhuis
  • Clinique Reine Astrid
  • Heilig Hartziekenhuis
  • Sint-Elisabethziekenhuis
  • Ziekenhuisgroep Twente
  • Amphia Ziekenhuis
  • Tjongerschans Ziekenhuis
  • Atrium Medisch Centrum
  • Ziekenhuisgroep Twente
  • Academisch Ziekenhuis Nijmegen St. Radbout
  • Gelre Ziekenhuizen

Outcomes

Primary Outcome Measures

Trough forced expiratory volume (FEV1) response after four weeks of treatment.

Secondary Outcome Measures

Trough FEV1 response after 1 and 2 weeks
Trough FVC response after 1, 2 and 4 weeks
FEV1, FVC AUC0-6h and peak response after 0, 1, 2 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 up to the three hour pulmonary function test (PFT)
12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)
drug plasma concentrations
drug urine concentrations

Full Information

First Posted
July 18, 2005
Last Updated
December 27, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00122434
Brief Title
Dose Finding Study in COPD
Official Title
A Randomized, Multiple-dose, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Study to Determine the Optimum Dose of BEA 2180 BR Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
May 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 is to determine the optimum dose of BEA 2180 BR inhalation solut ion 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
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
389 (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 after four weeks of treatment.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Trough FEV1 response after 1 and 2 weeks
Time Frame
after 1 and 2 weeks
Title
Trough FVC response after 1, 2 and 4 weeks
Time Frame
after 1, 2 and 4 weeks
Title
FEV1, FVC AUC0-6h and peak response after 0, 1, 2 and 4 weeks
Time Frame
after 0, 1, 2 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
7 weeks
Title
Pulse rate and blood pressure (seated) recorded in conjunction with spirometry up to the three hour pulmonary function test (PFT)
Time Frame
4 weeks
Title
12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose (Visits 2 and 5)
Time Frame
4 weeks
Title
drug plasma concentrations
Time Frame
4 or 7 weeks
Title
drug urine concentrations
Time Frame
4 or 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
83 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
UAB Lung Health Center
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Vapahcs 111P
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
GLAHS Sepulveda
City
Sepulveda
State/Province
California
Country
United States
Facility Name
Rehabilitation Clinical Trial Center
City
Torrance
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Hospital for Special Care
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Bay Pines VA Medical Center
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Panama City
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
LSUHSC - Shreveport
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
VAMC-Reno
City
Reno
State/Province
Nevada
Country
United States
Facility Name
North Shore Universtiy Hospital
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
SVMMC
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Frank Sciurba
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
MUSC
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Harker Heights
State/Province
Texas
Country
United States
Facility Name
MEDVAMC
City
Houston
State/Province
Texas
Country
United States
Facility Name
McGuire VA
City
Fredericksburg
State/Province
Virginia
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
Facility Name
CHU du Sart Tilman (B35)
City
Angleur
Country
Belgium
Facility Name
A.Z. VUB
City
Brussel
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
Country
Belgium
Facility Name
AZ Jan Palfijn
City
Gent
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Virga Jesseziekenhuis
City
Hasselt
Country
Belgium
Facility Name
Clinique Reine Astrid
City
Malmedy
Country
Belgium
Facility Name
Heilig Hartziekenhuis
City
Menen
Country
Belgium
Facility Name
Sint-Elisabethziekenhuis
City
Turnhout
Country
Belgium
Facility Name
Ziekenhuisgroep Twente
City
Almelo
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Tjongerschans Ziekenhuis
City
Heerenveen
Country
Netherlands
Facility Name
Atrium Medisch Centrum
City
Heerlen
Country
Netherlands
Facility Name
Ziekenhuisgroep Twente
City
Hengelo
Country
Netherlands
Facility Name
Academisch Ziekenhuis Nijmegen St. Radbout
City
Nijmegen
Country
Netherlands
Facility Name
Gelre Ziekenhuizen
City
Zutphen
Country
Netherlands

12. IPD Sharing Statement

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Dose Finding Study in COPD

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