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Original Research: BRONCHIECTASIS |

Clinical Efficacy and Safety of Budesonide-Formoterol in Non-Cystic Fibrosis BronchiectasisFormoterol-Budesonide Treatment in Bronchiectasis

Miguel Ángel Martínez-García, MD; Juan J. Soler-Cataluña, MD; Pablo Catalán-Serra, MD; Pilar Román-Sánchez, MD; Miguel Perpiñá Tordera, MD
Author and Funding Information

From the Pneumology Unit (Drs Martínez-García, Soler-Cataluña, and Catalán-Serra), the Internal Medicine Service (Dr Román-Sánchez), General Hospital of Requena; the Pneumology Service (Drs Martínez-García and Perpiñá Tordera), La Fe University Hospital, Valencia, Spain; and CIBERes de enfermedades Respiratorias (Dr Martínez-García), Valencia, Spain.

Correspondence to: Miguel Ángel Martínez-García, MD, La Fe University and Polytechnic Hospital, Av Bulevar Sur s/n, 46026, Valencia, Spain; e-mail: miangel@comv.es


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.


© 2012 American College of Chest Physicians


Chest. 2012;141(2):461-468. doi:10.1378/chest.11-0180
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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

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