Efficacy of Budesonide-Formoterol in Bronchiectasis

July 31, 2008 updated by: Hospital General de Requena

Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis

Some studies have concluded that high-dose inhaled steroids (IS) are effective in the clinical control of patients with bronchiectasis, however the high doses needed provokes some adverse effects and lower doses are not effective. Combined treatment with budesonide and formoterol have demostrated to be effective in patients with asthma and COPD achieving the reduction of steroid dose thanks to the adition of a long-acting beta 2 agonists. There are no studies in the literature analysing the effect of combined treatment in patients with bronchiectasis. The objective of this study is to compare the efficacy and safety of formoterol-medium dose of budesonide in a single inhaler versus high-dose of budesonide in the clinical control of patientes with non-cystic fibrosis bronchiectasis.

Study Design:

Randomized (3 months) parallel groups study.

Patients:

Patients with bronchiectasis diagnosed by high-resolution CT scan and chronic obstructive airway obstruction.

Exclusion:

Asthma and current or past smokers.

Methods:

Run in period in all patients with high dose of budesonide (1600 mcg/day) for 3 months. After that, randomization into two groups: 1. The same treatment (1600 mcg/day of budesonide) or combined treatment with lower dose of budesonide (18 mcg/day of formoterol and 800 mcg of budesonide) in a single turbuhaler inhaler during 3 months.

Studied variables:

Clinical, functional, quality of life, microbiological and number of side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • Spain
      • Valencia, Spain, 43260
        • Hospital General de Requena

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 years old patients diagnosed of non-cystic fibrosis bronchiectasis
  • More than 1 pulmonary lobe affected
  • Chronic obstructive airflow obstruction
  • Stable phase of the disease

Exclusion Criteria:

  • Asthma, COPD or current/past smnokers
  • No consent
  • Known intolerance to budesonide or formoterol

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Medium Dose of budesonide-formoterol
Drug: budesonide-formoterol single inhaler
High dose budesonide:Budesonide (Pulmocort turbuhaler) 400 mcg (2 inhalations bid) Medium dose budesonide plus formoterol (Rilast turbuhaler) 4,5 mcg of formoterol plus 400 mcg of budesonide: 2 inhalations bid
Other Names:
  • B. High-dose budesonide arm
  • A. Medium dose of budesonide plus formoterol
Drug: High dose of budesonide
1600 mcg/d of budesonide
Drug: A
medium dose of budesonide-formoterol
Active Comparator: B
High dose of inhaled budesonide (1600 mcg/day)
Drug: budesonide-formoterol single inhaler
High dose budesonide:Budesonide (Pulmocort turbuhaler) 400 mcg (2 inhalations bid) Medium dose budesonide plus formoterol (Rilast turbuhaler) 4,5 mcg of formoterol plus 400 mcg of budesonide: 2 inhalations bid
Other Names:
  • B. High-dose budesonide arm
  • A. Medium dose of budesonide plus formoterol
Drug: High dose of budesonide
1600 mcg/d of budesonide
Drug: B
High Dose Inhaled Budesonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life (measured by St Gorge Respiratory Questionnaire)
Time Frame: at 3 and 6 months
at 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects
Time Frame: at 3 and 6 months
at 3 and 6 months

Collaborators and Investigators

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

Sponsor

Hospital General de Requena

Collaborators

Esteve

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, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimate)

August 6, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2008

Last Update Submitted That Met QC Criteria

July 31, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGR-0000013

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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