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Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation

Primary Purpose

Bronchiectasis Adult

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
LABA/LAMA or Placebo inhalation
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic bronchiectasis with FEV1/FVC < 70%

Exclusion Criteria:

  • With Asthma
  • α-1 antitrypsin deficiency
  • Turculosis
  • Lung cancer
  • Sarcoidosis
  • Idiopathic pulmonary fibrosis
  • Primary pulmonary hypertension
  • Uncontrolled sleep apnea
  • Bronchiectasis accepted long-term low dose macrolides
  • Pulmonary surgery within 6 months
  • Lower respiratory tract infections require antibiotic treatment in 6 weeks
  • Upper respiratory tract infection did not recover for at least 7 days
  • With Glaucoma or severe prostate hyperplasia that can not use Indacaterol
  • Patients allergic to experimental drugs
  • Women pregnant, breast-feeding or who planned a pregnancy during the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.

    Placebo treatment for the airway limitation.

    Outcomes

    Primary Outcome Measures

    Actue exacerbation
    Times of acute exacerbation

    Secondary Outcome Measures

    modified Medical Research Council score
    modified Medical Research Council score for the degree of dyspnea. The minimum value is 0 and maximum value is 4. Higher scores mean a worse outcome.
    Leicester Cough Questionnaire
    Cough Questionnaire for the degree of cough. The minimum value is 1 and maximum value is 21. Higher scores mean a better outcome.
    Questionnaire of life-Bronchiectasis
    Including eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life.
    FEV1, FVC
    Forced Expiratory Volume In 1s and Forced Vital Capacity.
    FEV1%
    The percent of predicted Forced Expiratory Volume In 1s
    Incidence of atrial fibrillation
    One of common adverse events
    Incidence of coronary artery disease
    One of common adverse events

    Full Information

    First Posted
    April 22, 2020
    Last Updated
    August 11, 2020
    Sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04509661
    Brief Title
    Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation
    Official Title
    Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Pulmonary Hospital, Shanghai, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Airflow limitation is common exist in idiopathic bronchiectasis patients. However, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation. The efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation are still unclear. Thus, the investigators conduct a multicenter, open-label randomized controlled trial to investigate the efficacy and safety of dual bronchodilator in idiopathic bronchiectasis with airflow limitation.
    Detailed Description
    Airflow limitation is common exist in idiopathic bronchiectasis patients. Our previous studies showed that FEV1<50% is one of the major risk factors for poor prognosis and high incidence of acute exacerbation in patients with bronchiectasis. However, there are few evidence on the treatment of bronchodilator in bronchiectasis with airflow limitation, and there is no recommendation in bronchiectasis guidelines. Moreover, because of the high risk of infection and bacterial colonization in bronchiectasis, there is still unclear whether inhaled corticosteroids or bronchodilators affect the parameters of bronchiectasis. Thus, there is urgent need to optimize the treatment of bronchiectasis with airflow limitation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiectasis Adult

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo treatment for the airway limitation.
    Intervention Type
    Drug
    Intervention Name(s)
    LABA/LAMA or Placebo inhalation
    Other Intervention Name(s)
    Inhaled dual Bronchodilator
    Intervention Description
    Inhaled LABA/LAMA for one year.
    Primary Outcome Measure Information:
    Title
    Actue exacerbation
    Description
    Times of acute exacerbation
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    modified Medical Research Council score
    Description
    modified Medical Research Council score for the degree of dyspnea. The minimum value is 0 and maximum value is 4. Higher scores mean a worse outcome.
    Time Frame
    Six months
    Title
    Leicester Cough Questionnaire
    Description
    Cough Questionnaire for the degree of cough. The minimum value is 1 and maximum value is 21. Higher scores mean a better outcome.
    Time Frame
    Six months
    Title
    Questionnaire of life-Bronchiectasis
    Description
    Including eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life.
    Time Frame
    Six months
    Title
    FEV1, FVC
    Description
    Forced Expiratory Volume In 1s and Forced Vital Capacity.
    Time Frame
    Six months
    Title
    FEV1%
    Description
    The percent of predicted Forced Expiratory Volume In 1s
    Time Frame
    Six months
    Title
    Incidence of atrial fibrillation
    Description
    One of common adverse events
    Time Frame
    Six months
    Title
    Incidence of coronary artery disease
    Description
    One of common adverse events
    Time Frame
    Six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Idiopathic bronchiectasis with FEV1/FVC < 70% Exclusion Criteria: With Asthma α-1 antitrypsin deficiency Turculosis Lung cancer Sarcoidosis Idiopathic pulmonary fibrosis Primary pulmonary hypertension Uncontrolled sleep apnea Bronchiectasis accepted long-term low dose macrolides Pulmonary surgery within 6 months Lower respiratory tract infections require antibiotic treatment in 6 weeks Upper respiratory tract infection did not recover for at least 7 days With Glaucoma or severe prostate hyperplasia that can not use Indacaterol Patients allergic to experimental drugs Women pregnant, breast-feeding or who planned a pregnancy during the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jin-fu Xu, MD
    Phone
    +86 13321922898
    Email
    jfxucn@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jin-fu Xu, MD
    Organizational Affiliation
    Shanghai Pulmonary Hospital, Shanghai, China
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation

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