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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: ICS+LABA Other: routine therapy Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective Study
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ICS+LABA Group
Seretide 250，inhalation，twice daily，one year
 Drug: ICS+LABA
Seretide is inhaled for one year
Other Name: Seretide
Active Comparator: Control Group
routine therapy for one year
 Other: routine therapy
routine therapy for one year


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]
    CAT score

  2. Quality of life [ Time Frame: 12 months ]
    mMRC score

  3. Quality of life [ Time Frame: 12 months ]
    SGRQ score


Secondary Outcome Measures :
  1. pulmonary function text [ Time Frame: 12 months ]
    FEV1

  2. pulmonary function text [ Time Frame: 12 months ]
    FEV1% predicted

  3. pulmonary function text [ Time Frame: 12 months ]
    FEV1/FVC

  4. short-acting β2-adrenergic agonist (SABA) used [ Time Frame: 12 months ]
    Number of SABA needed per patient every week

  5. Exacerbations [ Time Frame: 12 months ]
    The times of acute exacerbation during the trial.

  6. sputum microorganism culture [ Time Frame: 12 months ]
    Number of microorganism isolates along the study

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782312


Locations
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China, Shanghai
Shanghai Pulmonary Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: Jin-Fu Xu Shanghai Pulmonary Hospital , Tongji University
More Information
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Publications of Results:

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Responsible Party: Jin-Fu Xu, Director of respiratory department, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT02782312    
Other Study ID Numbers: 20110505
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Keywords provided by Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China:
Bronchiectasis
ICS+LABA
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Fluticasone-Salmeterol Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics