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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00274560
First received: January 9, 2006
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  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 3

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

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
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00274560     History of Changes
Other Study ID Numbers: 205.264
Study First Received: January 9, 2006
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Aspiration
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Disease Attributes
Pathologic Processes
Salmeterol
Tiotropium
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 22, 2013