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Budesonide / Formoterol in Treatment of Exacerbations of COPD

AstraZeneca logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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