Budesonide / Formoterol in Treatment of Exacerbations of COPD - Tabular View

Tracking Information

First Received Date ^ICMJE

October 13, 2005

Last Updated Date

March 27, 2009

Start Date ^ICMJE

January 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00239278 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Budesonide / Formoterol in Treatment of Exacerbations of COPD

Official Title ^ICMJE

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.

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

January 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00239278

Responsible Party

Study ID Numbers ^ICMJE

SD-039-0698

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Netherlands Medical Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP