Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 227 for:    Bronchiectasis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782312
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Tracking Information
First Submitted Date  ICMJE May 17, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE June 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • 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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02782312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchiectasis
Intervention  ICMJE
  • Drug: ICS+LABA
    Seretide is inhaled for one year
    Other Name: Seretide
  • Other: routine therapy
    routine therapy for one year
Study Arms  ICMJE
  • Experimental: ICS+LABA Group
    Seretide 250,inhalation,twice daily,one year
    Intervention: Drug: ICS+LABA
  • Active Comparator: Control Group
    routine therapy for one year
    Intervention: Other: routine therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2016)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02782312
Other Study ID Numbers  ICMJE 20110505
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor  ICMJE Shanghai Pulmonary Hospital, Shanghai, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin-Fu Xu Shanghai Pulmonary Hospital , Tongji University
PRS Account Shanghai Pulmonary Hospital, Shanghai, China
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP