Tiotropium / Respimat One-Year Study - Full Text View

Purpose

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respima t 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)

ChemIDplus related topics:

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
Estimated Study Completion Date:	December 2005

Eligibility

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

Criteria

Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168831

Show 81 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators


Study Chair:	Boehringer Ingelheim Study Coordinator	Boehringer Ingelheim Pharmaceuticals

More Information

Study ID Numbers:	205.255
First Received:	September 12, 2005
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00168831
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

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 September 22, 2008

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00168831