Efficacy of Budesonide-Formoterol in Bronchiectasis

Not Applicable

Completed

• Conditions: Bronchiectasis
• Interventions: Drug: budesonide-formoterol single inhaler; Drug: High dose of budesonide; Drug: A; Drug: B

• Registration Number: NCT00728715
• Lead Sponsor: Hospital General de Requena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Status Verified: 2008-07
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-07-31
• Last Update Submitted: 2008-07-31
• Study First Posted: 2008-08-06
• Last Update Posted: 2008-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	budesonide-formoterol single inhaler	High dose of inhaled budesonide (1600 mcg/day)
A	budesonide-formoterol single inhaler	Medium Dose of budesonide-formoterol
A	High dose of budesonide	Medium Dose of budesonide-formoterol
A	A	Medium Dose of budesonide-formoterol
B	High dose of budesonide	High dose of inhaled budesonide (1600 mcg/day)
B	B	High dose of inhaled budesonide (1600 mcg/day)

Primary Outcome Measures

Name	Time	Method
Health related quality of life (measured by St Gorge Respiratory Questionnaire)	at 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
Forced spirometry; microbiological data, clinical data (dyspnea, cough, wheezes) and side effects	at 3 and 6 months

Trial Locations

Locations (1)

Hospital General de Requena; 🇪🇸 Valencia, Spain