The objective of this study is to assess the efficacy and safety of Salmeterol-Fluticasone (ICS and LABA)combined inhaled therapy for non-cystic fibrosis(non-CF)bronchiectasis patients with chronic airflow obstruction. Moreover, subgroup analysis is performed to explore which populations of bronchiectasis patients this treatment is suitable for.
Inhaled ICS and LABA have proved obvious benefit for asthma or chronic obstructive pulmonary disease (COPD) patients. However, there is presently no clear evidence on the effect of ICS and LABA combined inhaled therapy for non-CF bronchiectasis patients. This study is designed as a prospective, randomized,control trial. Patients are divided into two groups, one group inhaled with ICS and LABA (Seretide), another group received routine therapy (oxygen uptake, phlegm dissipation, hemostasis postural drainage and naturopathy).The course of treatment is 12 months. All patients underwent reviews at baseline entry to the study and at months 6 and 12 of treatment. The quality of life (QOL) scores:St George's dyspnea score (SGRQ score), modified british medical reserach council(mMRC score) and COPD assessment test (CAT score); lung function test: forced expiratory volume in one second (FEV1),FEV1% predicted, the ratio of forced expiratory volume in one second and forced vital capacity (FEV1/FVC%); short-acting β2-adrenergic agonist(SABA)use and the incidence of adverse event were monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Seretide is inhaled for one year
routine therapy for one year
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Quality of life
CAT score
Time frame: 12 months
Quality of life
mMRC score
Time frame: 12 months
Quality of life
SGRQ score
Time frame: 12 months
pulmonary function text
FEV1
Time frame: 12 months
pulmonary function text
FEV1% predicted
Time frame: 12 months
pulmonary function text
FEV1/FVC
Time frame: 12 months
short-acting β2-adrenergic agonist (SABA) used
Number of SABA needed per patient every week
Time frame: 12 months
Exacerbations
The times of acute exacerbation during the trial.
Time frame: 12 months
sputum microorganism culture
Number of microorganism isolates along the study
Time frame: 12 months
Number of patients with adverse events
All of the adverse events occurred in the processing of the trial,especially adverse events associated with inhaled corticosteroids
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Time frame: 12 months