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High Dose Trial in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128440
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : October 29, 2013
Information provided by:
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: BEA 2180 BR Drug: tiotropium Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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)
Study Start Date : August 2005
Actual Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Primary Outcome Measures :
  1. Trough forced expiratory volume (FEV1) response [ Time Frame: baseline to 24 hours post drug administration ]
  2. 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 Measures :
  1. Trough FVC response after 4 weeks [ Time Frame: after 4 weeks ]
  2. FEV1 and FVC peak response after 0 and 4 weeks [ Time Frame: after 0 and 4 weeks ]
  3. FVC AUC0-6h after 0 and 4 weeks [ Time Frame: after 0 and 4 weeks ]
  4. Individual FEV1 and FVC measurements at each time point [ Time Frame: 4 weeks ]
  5. Weekly mean pre-dose morning and evening PEFR [ Time Frame: 4 weeks ]
  6. Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol] [ Time Frame: 4 weeks ]
  7. COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest [ Time Frame: 4 weeks ]
  8. Physician's Global Evaluation [ Time Frame: 4 weeks ]
  9. All adverse events [ Time Frame: 28 weeks ]
  10. Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing [ Time Frame: 28 weeks ]
  11. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128440

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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
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OverallOfficial: Boehringer Ingelheim Study Coordinator

Layout table for additonal information Identifier: NCT00128440    
Other Study ID Numbers: 1205.6
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action