Effect of Tiotropium Plus Salmeterol vs. Fluticasone/Salmeterol on Static Lung Volumes and Exercise Endurance in COPD

NCT00530842 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2013-12-24

Study results available
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Summary

The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD.

The secondary objective includes assessment of safety.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Tiotropium plus Salmeterol

DRUG

Fluticasone/Salmeterol

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-01-31

Countries

  • Austria
  • Canada
  • France
  • Germany
  • Italy
  • Russia
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00530842 on ClinicalTrials.gov