Dose Finding Study in COPD - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00122434

Purpose

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.

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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint is trough FEV1 response determined at the end of the four-week treatment period. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing

Secondary Outcome Measures:

Trough FEV1 response after 1 and 2 weeks Trough FVC response after 1, 2, and 4 weeks FEV1 and FVC AUC0-6h and peak response after 0, 1, 2, and 4 weeks Individual FEV1 and FVC measurements at each time point

Estimated Enrollment:	378
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	40 Years to 83 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122434

Show 43 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Investigator:

Boehringer Ingelheim Study Coordinator

More Information

Study ID Numbers:	1205.4
Study First Received:	July 18, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00122434
Health Authority:	Unspecified

Study placed in the following topic categories:

Signs and Symptoms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Chronic Disease
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Disease Attributes
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009