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

Brief Title

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

Official Title

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

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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

Quality of life

Secondary Outcome

 pulmonary function text

Condition

Bronchiectasis

Intervention

ICS+LABA

Study Arms / Comparison Groups

 ICS+LABA Group

Description:  Seretide 250，inhalation，twice daily，one year

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

120

Start Date

June 2011

Completion Date

June 2013

Primary Completion Date

June 2012

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jin-Fu Xu, , 

Location Countries

China

Location Countries

China

NCT ID

NCT02782312

Organization ID

20110505

Responsible Party

Principal Investigator

Study Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Study Sponsor

Jin-Fu Xu, Principal Investigator, Shanghai Pulmonary Hospital , Tongji University

Verification Date

May 2016