Budesonide / Formoterol in Treatment of Exacerbations of COPD

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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