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 Information
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
Administrative Informations
NCT ID
NCT00728715
Organization ID
HGR-0000013
Study Sponsor
Hospital General de Requena
Collaborators
Esteve
Study Sponsor
, ,
Verification Date
July 2008