High Dose Trial in COPD - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00128440

Purpose

The primary objective of this study is to compare the efficacy and safety of 200 ?g and 400 ?g of BE A 2180 to tiotropium 5 ?g and placebo when each is delivered by the Respimat Inhaler once daily for four weeks in patients with Chronic Obstructive Pulmonary Disease (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: 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 ?g and 400 ?g of BEA 2180 BR to Tiotropium 5 ?g and Placebo When Each is 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 efficacy variable will be forced expiratory volume in one second (FEV1). The two primary endpoints will be trough FEV1 response and FEV1 AUC0-6h after four weeks of treatment.

Secondary Outcome Measures:

Trough FVC (forced vital capacity) response after 4 weeks FEV1 and FVC peak response after 0 and 4 weeks FVC AUC0-6h after 0 and 4 weeks Individual FEV1 and FVC measurements at each time point

Estimated Enrollment:	75
Estimated Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	40 Years to 84 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: 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 Pharmaceuticals

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:	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