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Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD

NCT00489853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2012-08-30

Study results available
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Summary

The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.

Conditions

Interventions

DRUG

budesonide/formoterol Turbuhaler 320/9µg

Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms

DRUG

formoterol Turbuhaler 9µg

Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily

OTHER

Placebo

Placebo, 1 inhalation twice daily

Sponsors & Collaborators

Principal Investigators

  • Tomas Andersson, MD · AstraZeneca

  • Heinrich Worth, MD · Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00489853 on ClinicalTrials.gov