Budesonide / Formoterol in Treatment of Exacerbations of COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239278
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : January 24, 2011
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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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: budesonide/formoterol, 2x 200/6 microgram. 4 times daily Drug: prednisolone, 30 mg once daily and placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2001
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: budesonide/formoterol, 2x 200/6 microgram. 4 times daily
    Other Name: Symbicort
    Drug: prednisolone, 30 mg once daily and placebo

Primary Outcome Measures :
  1. 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 Measures :
  1. Inflammatory markers in induced sputum, blood/serum and urine
  2. Lung function tests at clinic
  3. Diary cards for PEF and symptoms
  4. Patient Related outcomes
  5. Questioning for Adverse Events and in blood: routine tests and cortisol

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239278

Research Site
Groningen, Netherlands
Sponsors and Collaborators
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00239278     History of Changes
Other Study ID Numbers: SD-039-0698
D5892C00698 ( Other Identifier: AstraZeneca )
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists