Efficacy of Budesonide-Formoterol in Bronchiectasis

Brief Title

Efficacy of Budesonide-Formoterol in Bronchiectasis

Official Title

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

Brief Summary

      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 Type

Interventional

Primary Outcome

Health related quality of life (measured by St Gorge Respiratory Questionnaire)

Secondary Outcome

 Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects

Condition

Bronchiectasis

Intervention

budesonide-formoterol single inhaler

Study Arms / Comparison Groups

 A

Description:  Medium Dose of budesonide-formoterol

Publications

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

Recruitment Status

Drug

Estimated Enrollment

40

Start Date

January 2004

Completion Date

January 2005

Primary Completion Date

January 2005

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Spain

Location Countries

Spain

NCT ID

NCT00728715

Organization ID

HGR-0000013

Study Sponsor

Hospital General de Requena

Collaborators

 Esteve

Study Sponsor

, , 

Verification Date

July 2008