Budesonide / Formoterol in Treatment of Exacerbations of COPD

AstraZeneca120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

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

prednisolone, 30 mg once daily and placeboDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Groningen, Netherlands

Outcomes

Primary Outcomes

Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment

Secondary Outcomes

Inflammatory markers in induced sputum, blood/serum and urine

Lung function tests at clinic

Diary cards for PEF and symptoms

Patient Related outcomes

Questioning for Adverse Events and in blood: routine tests and cortisol

Data from ClinicalTrials.gov

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