Effects of High Dose Inhaled Budesonide+ Formoterol Versus Placebo and Oral Prednisolone on Biomarkers of Airway Inflammation in the Treatment of Exacerbations in Non-hospitalised Patients With Mild to Moderate COPD.

AstraZeneca1 site in 1 country120 target enrollmentStarted: January 2001Last updated: January 24, 2011

Conditions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: AstraZeneca
Enrollment: 120
Locations: 1
Primary Endpoint: Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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 Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Double

Eligibility Criteria

Ages: 40 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

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

Investigators

Sponsor

AstraZeneca

Sponsor Class

Industry

Study Sites (1)

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