Clinical trial NCT00728715: Efficacy of Budesonide-Formoterol in Bronchiectasis
Official title: Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Budesonide
Formoterol
Non cystic fibrosis bronchiectasis
Lead sponsor: Hospital General de Requena
Sponsor class: OTHER
Collaborators: name: Esteve
First posted: 2008-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Health related quality of life (measured by St Gorge Respiratory Questionnaire)
timeFrame: at 3 and 6 months
Secondary outcomes:
measure: Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects
timeFrame: at 3 and 6 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital General de Requena
Study officials:
References:
citation: Martinez-Garcia MA, Soler-Cataluna JJ, Catalan-Serra P, Roman-Sanchez P, Tordera MP. Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis. Chest. 2012 Feb;141(2):461-468. doi: 10.1378/chest.11-0180. Epub 2011 Jul 21.