Budesonide / Formoterol in Treatment of Exacerbations of COPD

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: budesonide/formoterol, 2x 200/6 microgram. 4 times daily; Drug: prednisolone, 30 mg once daily and placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239278

SD-039-0698

D5892C00698 (Other Identifier)

Details and patient eligibility

About

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

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind