Budesonide / Formoterol in Treatment of Exacerbations of COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-01-31

Brief Summary

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The purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of COPD with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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budesonide/formoterol, 2x 200/6 microgram. 4 times daily

Intervention Type DRUG

prednisolone, 30 mg once daily and placebo

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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Inclusion Criteria

* smoking-induced COPD according to ATS criteria
* FEV1 \<85% of predicted at enrolment and \<70% of predicted but \> 0.7 Liter at Exacerbation
* FEV1/IVC ratio \<88% of predicted for men and \<89% for women

Exclusion Criteria

* history of asthma
* known hypersensitivity to the study drugs
* serious concomitant diseases
* pregnancy or lactating
* abnormal Chest X-ray or blood gasses

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No