NCT00728715

Efficacy of Budesonide-Formoterol in Bronchiectasis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital General de Requena · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
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
DRUG	High dose of budesonide	1600 mcg/d of budesonide
DRUG	A	medium dose of budesonide-formoterol
DRUG	B	High Dose Inhaled Budesonide

Timeline

• Start date: 2004-01-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2008-08-06
• Last updated: 2008-08-06

Locations

1 site across 1 country: Spain