Clinical Trial: Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary:

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.


Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Current Primary Outcome:

  • Quality of life [ Time Frame: 12 months ]
    CAT score
  • Quality of life [ Time Frame: 12 months ]
    mMRC score
  • Quality of life [ Time Frame: 12 months ]
    SGRQ score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • pulmonary function text [ Time Frame: 12 months ]
    FEV1
  • pulmonary function text [ Time Frame: 12 months ]
    FEV1% predicted
  • pulmonary function text [ Time Frame: 12 months ]
    FEV1/FVC
  • short-acting β2-adrenergic agonist (SABA) used [ Time Frame: 12 months ]
    Number of SABA needed per patient every week
  • Exacerbations [ Time Frame: 12 months ]
    The times of acute exacerbation during the trial.
  • sputum microorganism culture [ Time Frame: 12 months ]
    Number of microorganism isolates along the study
  • Number of patients with adverse events [ Time Frame: 12 months ]
    All of the adverse events occurred in the processing of the trial,especially adverse events associated with inhaled corticosteroids


Original Secondary Outcome: Same as current

Information By: Shanghai Pulmonary Hospital, Shanghai, China

Dates:
Date Received: May 17, 2016
Date Started: June 2011
Date Completion:
Last Updated: May 25, 2016
Last Verified: May 2016