A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.

This study has been completed.

First Received: January 9, 2006 Last Updated: July 6, 2009 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00274560

Purpose

The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study 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: Salmeterol Salmeterol xinafoate Tiotropium bromide Tiotropium

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

There were two primary endpoints: FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12) and peak FEV1. Both endpoints were measured after 12 weeks of treatment, at the final study visit (Visit 4).

Secondary Outcome Measures:

Trough (predose) FEV1 Trough, peak and FVC AUC0-12 FEV1 and FVC at individual timepoints Amount of albuterol therapy used during the treatment period Number (%) of patients with at one exacerbation of COPD and time to first exacerbation

Estimated Enrollment:	600
Study Start Date:	May 2002
Estimated Study Completion Date:	October 2003

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: NCT00274560

Show 50 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	205.264
Study First Received:	January 9, 2006
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00274560 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Salmeterol
Cholinergic Antagonists
Adrenergic Agents
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Cholinergic Agents
Adrenergic Agonists

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Disease Attributes
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

Therapeutic Uses
Tiotropium
Salmeterol
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Chronic Disease
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 02, 2009