Clinical trial NCT02782312: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiectasis
Keywords: Bronchiectasis
ICS+LABA
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
Secondary outcomes:
measure: pulmonary function text
timeFrame: 12 months
measure: pulmonary function text
timeFrame: 12 months
measure: pulmonary function text
timeFrame: 12 months
measure: short-acting β2-adrenergic agonist (SABA) used
timeFrame: 12 months
measure: Exacerbations
timeFrame: 12 months
measure: sputum microorganism culture
timeFrame: 12 months
measure: Number of patients with adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital , Tongji University
name: Jin-Fu Xu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez-Garcia MA, Soler-Cataluna JJ, Catalan-Serra P, Roman-Sanchez P, Tordera MP. Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis. Chest. 2012 Feb;141(2):461-468. doi: 10.1378/chest.11-0180. Epub 2011 Jul 21.
citation: Tsang KW, Tan KC, Ho PL, Ooi GC, Ho JC, Mak J, Tipoe GL, Ko C, Yan C, Lam WK, Chan-Yeung M. Inhaled fluticasone in bronchiectasis: a 12 month study. Thorax. 2005 Mar;60(3):239-43. doi: 10.1136/thx.2002.003236.
citation: Goyal V, Chang AB. Combination inhaled corticosteroids and long-acting beta2-agonists for children and adults with bronchiectasis. Cochrane Database Syst Rev. 2014 Jun 10;2014(6):CD010327. doi: 10.1002/14651858.CD010327.pub2.