Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis

Phase 4

Completed

• Conditions: Bronchiectasis
• Interventions: Drug: ICS+LABA; Other: routine therapy

• Registration Number: NCT02782312
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2013-06
• Status Verified: 2016-05
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• stable bronchiectasis; have the ability to complete the pulmonary function tests; FEV1/FVC<70%; ≥2 exacerbations within the past year

Exclusion Criteria

• a cigarette smoking history more than 10 pack-years;cystic fibrosis or traction bronchiectasis due to various pulmonary fibrosis; an active pulmonary mycobacterial infection; fungal infection; active sarcoidosis; active allergic bronchopulmonary aspergillosis (ABPA); asthma as defined by the Global Initiative for Asthma (GINA); patients with severe cardiopulmonary dysfunction; with impaired hepatic or kidney function; with hypogammaglobulinemia or other autoimmune diseases; pregnant or breast-feeding women; or patients with a known intolerance for ICS or LABAs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICS+LABA Group	ICS+LABA	Seretide 250，inhalation，twice daily，one year
Control Group	routine therapy	routine therapy for one year

Primary Outcome Measures

Name	Time	Method
Quality of life	12 months	SGRQ score

Secondary Outcome Measures

Name	Time	Method
pulmonary function text	12 months	FEV1/FVC
short-acting β2-adrenergic agonist (SABA) used	12 months	Number of SABA needed per patient every week
Exacerbations	12 months	The times of acute exacerbation during the trial.
sputum microorganism culture	12 months	Number of microorganism isolates along the study
Number of patients with adverse events	12 months	All of the adverse events occurred in the processing of the trial,especially adverse events associated with inhaled corticosteroids

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China