High Dose Trial in COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00128440
First received: August 9, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: BEA 2180 BR
Drug: tiotropium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough forced expiratory volume (FEV1) response [ Time Frame: baseline to 24 hours post drug administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FVC response after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
  • FEV1 and FVC peak response after 0 and 4 weeks [ Time Frame: after 0 and 4 weeks ] [ Designated as safety issue: No ]
  • FVC AUC0-6h after 0 and 4 weeks [ Time Frame: after 0 and 4 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1 and FVC measurements at each time point [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Weekly mean pre-dose morning and evening PEFR [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Evaluation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: August 2005
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128440

Locations
United States, California
Boehringer Ingelheim Investigational Site
Lakewood, California, United States
United States, Colorado
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
United States, Florida
Boehringer Ingelheim Investigational Site
Pembroke Farms, Florida, United States
United States, Idaho
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
United States, Nevada
Boehringer Ingelheim Investigational Site
Reno, Nevada, United States
United States, New York
Boehringer Ingelheim Investigational Site
Larchmont, New York, United States
United States, North Carolina
Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
United States, South Carolina
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
Boehringer Ingelheim Investigational Site
Harker Heights, Texas, United States
Boehringer Ingelheim Investigational Site
Houston, Texas, United States
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Virginia
Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
United States, Washington
Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Investigator: Boehringer Ingelheim Study Coordinator
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00128440     History of Changes
Other Study ID Numbers: 1205.6
Study First Received: August 9, 2005
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014