Budesonide / Formoterol in Treatment of Exacerbations of COPD

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

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

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Netherlands Medical Director, MD, Study Director, Affiliation: AstraZeneca

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

Official title: 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.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Research Site, Groningen, Netherlands

Starting date: January 2001
Last updated: October 13, 2005