Dose Finding Study in COPD - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Tiotropium

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012