Budesonide / Formoterol in Treatment of Exacerbations of COPD

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00239278
First received: October 13, 2005
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 120
Study Start Date: January 2001
Study Completion Date: January 2005
Intervention Details:
    Drug: budesonide/formoterol, 2x 200/6 microgram. 4 times daily
    Other Name: Symbicort
    Drug: prednisolone, 30 mg once daily and placebo
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239278

Locations
Netherlands
Research Site
Groningen, Netherlands
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Netherlands Medical Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00239278     History of Changes
Other Study ID Numbers: SD-039-0698, D5892C00698
Study First Received: October 13, 2005
Last Updated: January 21, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Symbicort
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Bronchodilator Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 23, 2014