Efficacy of Budesonide-Formoterol in Bronchiectasis
Status:
Completed
Trial end date:
2005-01-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Hospital General de Requena
Collaborators:
Esteve Esteve Labs (Grant)
Treatments:
Budesonide Budesonide, Formoterol Fumarate Drug Combination Formoterol Fumarate