Back to resultsBudesonide / Formoterol in Treatment of Exacerbations of COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
budesonide/formoterol, 2x 200/6 microgram. 4 times daily
prednisolone, 30 mg once daily and placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility 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
Sites / Locations
- Research Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00239278
Brief Title
Budesonide / Formoterol in Treatment of Exacerbations of COPD
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol, 2x 200/6 microgram. 4 times daily
Other Intervention Name(s)
Symbicort
Intervention Type
Drug
Intervention Name(s)
prednisolone, 30 mg once daily and placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Inflammatory markers in induced sputum, blood/serum and urine
Title
Lung function tests at clinic
Title
Diary cards for PEF and symptoms
Title
Patient Related outcomes
Title
Questioning for Adverse Events and in blood: routine tests and cortisol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Netherlands Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
18972276
Citation
Bathoorn E, Liesker JJ, Postma DS, Boorsma M, Bondesson E, Koeter GH, Kauffman HF, van Oosterhout AJ, Kerstjens HA. Anti-inflammatory effects of combined budesonide/formoterol in COPD exacerbations. COPD. 2008 Oct;5(5):282-90. doi: 10.1080/15412550802363360.
Results Reference
derived
PubMed Identifier
17296644
Citation
Bathoorn E, Liesker J, Postma D, Koeter G, van Oosterhout AJ, Kerstjens HA. Safety of sputum induction during exacerbations of COPD. Chest. 2007 Feb;131(2):432-8. doi: 10.1378/chest.06-2216.
Results Reference
derived
Learn more about this trial
Budesonide / Formoterol in Treatment of Exacerbations of COPD
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