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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782312
• Other study ID #: 20110505
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2016
• Last updated: May 25, 2016
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: May 2016
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• ICS+LABA
Seretide is inhaled for one year

Other:
• routine therapy
routine therapy for one year

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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;6:CD010327. doi: 10.1002/14651858.CD010327.pub2. Review. — View Citation

Martínez-García MÁ, Soler-Cataluña JJ, Catalán-Serra P, Román-Sánchez P, Tordera MP. Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis. Chest. 2012 Feb;141(2):461-8. doi: 10.1378/chest.11-0180. Epub 2011 Jul 21. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	CAT score	12 months	No
Primary	Quality of life	mMRC score	12 months	No
Primary	Quality of life	SGRQ score	12 months	No
Secondary	pulmonary function text	FEV1	12 months	No
Secondary	pulmonary function text	FEV1% predicted	12 months	No
Secondary	pulmonary function text	FEV1/FVC	12 months	No
Secondary	short-acting ß2-adrenergic agonist (SABA) used	Number of SABA needed per patient every week	12 months	No
Secondary	Exacerbations	The times of acute exacerbation during the trial.	12 months	No
Secondary	sputum microorganism culture	Number of microorganism isolates along the study	12 months	No
Secondary	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	Yes