Chest
Volume 141, Issue 2, February 2012, Pages 461-468
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Original Research
Bronchiectasis
Clinical Efficacy and Safety of Budesonide-Formoterol in Non-Cystic Fibrosis Bronchiectasis

https://doi.org/10.1378/chest.11-0180Get rights and content

Background

The aim of this study is to evaluate the efficacy and safety of medium-dose formoterol-budesonide combined inhaled treatment in a single inhaler compared with high-dose budesonide treatment in patients with non-cystic fibrosis (non-CF) bronchiectasis.

Methods

This is a 12-month randomized, double-blind, parallel-groups clinical trial, to run in 40 patients with non-CF bronchiectasis diagnosed by high-resolution CT scan of the chest, receiving formoterol-budesonide combined treatment (18/640 μg daily) or budesonide treatment (1,600 μg daily). Variables concerning clinical condition, health-related quality of life (HRQL), lung function, β2-adrenergic agonist use, potentially pathogenic microorganism (PPM) isolates, and medication side effects were analyzed by intention-to-treat analysis.

Results

The study group receiving a formoterol-budesonide combined treatment showed a significant improvement, both clinically and statistically, of symptoms (dyspnea, number of coughs, and rescue β2-adrenergic agonist-free days). Furthermore, we observed an HRQL improvement, with no changes in functional parameters or in PPM isolates, together with an important reduction in overall side effects, especially for those related to inhaled steroids, compared with the high-dose budesonide treatment group.

Conclusions

Inhaled medium-dose formoterol-budesonide combined treatment in a single inhaler is more effective and safe compared with high-dose budesonide treatment in patients with non-CF bronchiectasis.

Trial registry

ClinicalTrials.gov; No.: NCT00728715; URL: www.clinicaltrials.gov

Section snippets

Patients

We studied all patients between 18 and 80 years old with non-CF bronchiectasis diagnosed in our center. Inclusion criteria were known chronic airflow obstruction and clinically stable phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study). Exclusion criteria were cigarette smoking history of > 10 pack-years, occupational risk for COPD, chronic oral steroid treatment, traction bronchiectasis due to advanced fibrosis, known intolerance for ICS or

Results

Out of the 131 patients initially considered, 88 presented airflow obstruction. Out of these patients, 43 remained in the study after inclusion and exclusion criteria. During the run-in period, three additional patients were excluded for clinical instability following the change of treatment to high-dose budesonide. Finally, 40 patients were suitable for randomization (Fig 1). The causes finally identified were idiopathic in 19 cases (47.5%), postinfection in nine cases (22.5%), post TB in

Discussion

According to our results, formoterol plus medium-dose budesonide combined treatment showed a better clinical effectiveness and safety profile than high-dose budesonide treatment. Combined treatment caused a significant improvement, both statistically and clinically, of dyspnea, a decrease in number of cough days and wheeze self-perceived by patient, a reduction in the dose of rescue β2-agonist needed, and an improvement of HRQL, as well as a decrease in the percentage of side effects. Despite

Acknowledgments

Author contributions: Dr Martínez-García: contributed to designing the study, data acquisition and interpretation, supervising the study, and writing the manuscript.

Dr Soler-Cataluña: contributed to designing the study, data acquisition and interpretation, and approving the final version to be published.

Dr Catalán-Serra: contributed to data acquisition and interpretation, critically revised the manuscript, and approved the final version to be published.

Dr Román-Sánchez: contributed to data

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      A Cochrane review of inhaled corticosteroid (ICS) use in bronchiectasis concluded that the evidence did not support routine use of ICS and posed a risk of adverse effects.57 Evidence for long term use of inhaled long-acting β-agonists (LABA) in stable bronchiectasis is limited to one unblinded trial in 40 subjects, comparing combined ICS/LABA (budesonide 640 μg and formoterol 18 μg) with high dose ICS (budesonide 1600 μg).58 Patients who received ICS/LABA had less dyspnoea and more cough-free days after 3 months of treatment than those on ICS alone, with no difference in lung function or exacerbations.

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    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).

    Funding/Support: This study has received a grant from Esteve S.A. and Sociedad Valenciana de Neumología.

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