BACKGROUND: The effects of inhaled steroids upon the quality of life of patients with bronchiectasis remain unknown. STUDY OBJECTIVE: To analyze the effect of inhaled fluticasone propionate (FP) for 6 months upon the clinical, functional, microbiological and outcome parameters of patients with steady-state bronchiectasis not due to cystic fibrosis, and its repercussions for patient health-related quality of life (HRQoL). DESIGN: Prospective, randomized, double-blind (for effective doses) study. PATIENTS AND INTERVENTIONS: The diagnosis of bronchiectasis was made by high-resolution computed tomography. Ninety-three patients (mean age: 68.5 [8.4]) were randomized to receive 250 microg bid, 500 microg bid or no treatment with inhaled FP for 6 months. Data were collected at baseline and at 1, 3 and 6 months after the start of treatment. HRQoL was assessed using the validated Spanish version of the St. George's Respiratory Questionnaire. RESULTS: The group administered FP 1000 microg daily showed significant improvement in dyspnea (1.03 [2.1]-1.24 [2.2] points; P = 0.01-0.04), sputum production (P = 0.001), days without cough (P = 0.02) and short-acting beta-2 agonists used (P = 0.01) from the first month of treatment, with no changes in pulmonary function, number or severity of exacerbations, or microbiological profile of the sputum. As a result, an improvement in HRQoL was seen in this group after 3 months of treatment (45.4 [14.2] vs. 40.5 [13.9]; P = 0.01). CONCLUSIONS:Inhalatory FP 500 microg bid is effective from the first month of treatment for controlling the symptoms of patients with steady-state bronchiectasis-thus ensuring a significant improvement in HRQoL.
RCT Entities:
BACKGROUND: The effects of inhaled steroids upon the quality of life of patients with bronchiectasis remain unknown. STUDY OBJECTIVE: To analyze the effect of inhaled fluticasone propionate (FP) for 6 months upon the clinical, functional, microbiological and outcome parameters of patients with steady-state bronchiectasis not due to cystic fibrosis, and its repercussions for patient health-related quality of life (HRQoL). DESIGN: Prospective, randomized, double-blind (for effective doses) study. PATIENTS AND INTERVENTIONS: The diagnosis of bronchiectasis was made by high-resolution computed tomography. Ninety-three patients (mean age: 68.5 [8.4]) were randomized to receive 250 microg bid, 500 microg bid or no treatment with inhaled FP for 6 months. Data were collected at baseline and at 1, 3 and 6 months after the start of treatment. HRQoL was assessed using the validated Spanish version of the St. George's Respiratory Questionnaire. RESULTS: The group administered FP 1000 microg daily showed significant improvement in dyspnea (1.03 [2.1]-1.24 [2.2] points; P = 0.01-0.04), sputum production (P = 0.001), days without cough (P = 0.02) and short-acting beta-2 agonists used (P = 0.01) from the first month of treatment, with no changes in pulmonary function, number or severity of exacerbations, or microbiological profile of the sputum. As a result, an improvement in HRQoL was seen in this group after 3 months of treatment (45.4 [14.2] vs. 40.5 [13.9]; P = 0.01). CONCLUSIONS: Inhalatory FP 500 microg bid is effective from the first month of treatment for controlling the symptoms of patients with steady-state bronchiectasis-thus ensuring a significant improvement in HRQoL.
Authors: Rosana Hernando; María Estrella Drobnic; María Jesús Cruz; Adelaida Ferrer; Pilar Suñé; J Bruno Montoro; Ramon Orriols Journal: Int J Clin Pharm Date: 2012-06-09