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

NCT ID: NCT00489853

Last Updated: 2012-08-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Symbicort then Formoterol then Placebo

Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily

Group Type EXPERIMENTAL

budesonide/formoterol Turbuhaler 320/9µg

Intervention Type DRUG

Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms

formoterol Turbuhaler 9µg

Intervention Type DRUG

Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily

Placebo

Intervention Type OTHER

Placebo, 1 inhalation twice daily

Formoterol then Symbicort then Placebo

Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily

Group Type EXPERIMENTAL

budesonide/formoterol Turbuhaler 320/9µg

Intervention Type DRUG

Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms

formoterol Turbuhaler 9µg

Intervention Type DRUG

Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily

Placebo

Intervention Type OTHER

Placebo, 1 inhalation twice daily

Placebo then Formoterol then Symbicort

Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily

Group Type PLACEBO_COMPARATOR

budesonide/formoterol Turbuhaler 320/9µg

Intervention Type DRUG

Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms

formoterol Turbuhaler 9µg

Intervention Type DRUG

Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily

Placebo

Intervention Type OTHER

Placebo, 1 inhalation twice daily

Interventions

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budesonide/formoterol Turbuhaler 320/9µg

Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms

Intervention Type DRUG

formoterol Turbuhaler 9µg

Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily

Intervention Type DRUG

Placebo

Placebo, 1 inhalation twice daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>=40 years of age
* diagnosed COPD with symptoms \>= 2 years
* pre-bronchodilatory FEV1 \<=50% of PN

Exclusion Criteria

* Current respiratory tract disorder other than COPD
* history of asthma or rhinitis
* significant or unstable cardiovascular disorder
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tomas Andersson, MD

Role: STUDY_DIRECTOR

AstraZeneca

Heinrich Worth, MD

Role: PRINCIPAL_INVESTIGATOR

Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany

Locations

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Research Site

Berlin, , Germany

Site Status

Research Site

Erfurt, , Germany

Site Status

Research Site

Fulda, , Germany

Site Status

Research Site

Fürth, , Germany

Site Status

Research Site

Geesthacht, , Germany

Site Status

Research Site

Grobhansdorf, , Germany

Site Status

Research Site

Leipzig, , Germany

Site Status

Research Site

Neuruppin, , Germany

Site Status

Research Site

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Germany Switzerland

References

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Worth H, Forster K, Eriksson G, Nihlen U, Peterson S, Magnussen H. Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD. Respir Med. 2010 Oct;104(10):1450-9. doi: 10.1016/j.rmed.2010.07.006. Epub 2010 Aug 7.

Reference Type DERIVED
PMID: 20692140 (View on PubMed)

Other Identifiers

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Eudract No: 2006-006519-60

Identifier Type: -

Identifier Source: secondary_id

D5892C00014

Identifier Type: -

Identifier Source: org_study_id