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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective Study

Conditions
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Bronchiectasis

Intervention / Treatment
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* Drug: ICS+LABA
* Other: routine therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICS+LABA Group<br>Seretide 250，inhalation，twice daily，one year | Drug: ICS+LABA<br>* Seretide is inhaled for one year<br>* Other names: Seretide;|
| Active Comparator: Control Group<br>routine therapy for one year | Other: routine therapy<br>* routine therapy for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | CAT score | 12 months | 
| Quality of life | mMRC score | 12 months | 
| Quality of life | SGRQ score | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function text | FEV1 | 12 months | 
| pulmonary function text | FEV1% predicted | 12 months | 
| pulmonary function text | FEV1/FVC | 12 months | 
| short-acting β2-adrenergic agonist (SABA) used | Number of SABA needed per patient every week | 12 months | 
| Exacerbations | The times of acute exacerbation during the trial. | 12 months | 
| sputum microorganism culture | Number of microorganism isolates along the study | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiectasis, ICS+LABA