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 Information
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
Administrative Informations
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