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Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.

NCT00496470 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2012-11-09

Study results available
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Summary

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

Conditions

  • Chronic Obstructive Pulmonary Disease, COPD

Interventions

DRUG

Symbicort (budesonide/formoterol turbuhaler 320/9ug)

Symbicort (budesonide/formoterol turbuhaler 320/9ug)

DRUG

Spiriva (tiotropium bromide 18ug)

Spiriva (tiotropium bromide 18ug)

Sponsors & Collaborators

Principal Investigators

  • Tomas Andersson, MD · AstraZeneca R&D Lund

  • Tobias Welte, MD · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Australia
  • Canada
  • France
  • Germany
  • Hungary
  • Poland
  • Slovakia
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT00496470 on ClinicalTrials.gov