Efficacy of Budesonide-Formoterol in Bronchiectasis

Hospital General de Requena

Status: Completed

Conditions: Bronchiectasis

Treatments: Drug: A; Drug: High dose of budesonide; Drug: B; Drug: budesonide-formoterol single inhaler

Study type: Interventional

Funder types: Other

Identifiers

NCT00728715

HGR-0000013

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

A

Experimental group

Description:

Medium Dose of budesonide-formoterol

Treatment:

Drug: budesonide-formoterol single inhaler

Drug: High dose of budesonide

Drug: A

B

Active Comparator group

Description:

High dose of inhaled budesonide (1600 mcg/day)

Treatment:

Drug: budesonide-formoterol single inhaler

Drug: High dose of budesonide

Drug: B