Tiotropium / Respimat One-Year Study - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00168844

Purpose

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Tiotropium Inhalation Solution	Phase III

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 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Change in FEV1 (bronchodilator efficacy); Change in SGRQ (quality of life); Change in Mahler TDI (effect on dyspnoea); change in frequency of exacerbations.

Secondary Outcome Measures:

Adverse event monitoring; Holter / ECG monitoring / clinical laboratory measurements (all safety outcomes)

Estimated Enrollment:	960
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2005

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168844

Show 76 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Study ID Numbers:	205.254
Study First Received:	September 12, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00168844
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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 13, 2009