Budesonide / Formoterol in Treatment of Exacerbations of COPD

January 21, 2011 updated by: AstraZeneca

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-039-0698
  • D5892C00698 (Other Identifier: AstraZeneca)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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