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

Tracking Information

First Received Date ^ICMJE

January 9, 2006

Last Updated Date

May 14, 2012

Start Date ^ICMJE

May 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00274560 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

Brief Summary

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 .

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Disease, Chronic Obstructive

Intervention ^ICMJE

Drug: Tiotropium
Drug: Salmeterol

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

600

Completion Date

October 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Not Provided

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Finland, Greece, Italy, Portugal, Sweden, Turkey, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00274560

Other Study ID Numbers ^ICMJE

205.264

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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