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

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ClinicalTrials.gov Identifier: NCT04509661
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Adult Drug: LABA/LAMA or Placebo inhalation Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.
 Drug: LABA/LAMA or Placebo inhalation
Inhaled LABA/LAMA for one year.
Other Name: Inhaled dual Bronchodilator
Placebo Comparator: Control group
Placebo treatment for the airway limitation.
 Drug: LABA/LAMA or Placebo inhalation
Inhaled LABA/LAMA for one year.
Other Name: Inhaled dual Bronchodilator


Outcome Measures
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Primary Outcome Measures :
  1. Actue exacerbation [ Time Frame: One year ]
    Times of acute exacerbation


Secondary Outcome Measures :
  1. modified Medical Research Council score [ Time Frame: Six months ]
    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.

  2. Leicester Cough Questionnaire [ Time Frame: Six months ]
    Cough Questionnaire for the degree of cough. The minimum value is 1 and maximum value is 21. Higher scores mean a better outcome.

  3. Questionnaire of life-Bronchiectasis [ Time Frame: Six months ]
    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.

  4. FEV1, FVC [ Time Frame: Six months ]
    Forced Expiratory Volume In 1s and Forced Vital Capacity.

  5. FEV1% [ Time Frame: Six months ]
    The percent of predicted Forced Expiratory Volume In 1s

  6. Incidence of atrial fibrillation [ Time Frame: Six months ]
    One of common adverse events

  7. Incidence of coronary artery disease [ Time Frame: Six months ]
    One of common adverse events


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:

  • 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
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): NCT04509661


Contacts
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Contact: Jin-fu Xu, MD +86 13321922898 jfxucn@163.com

Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Study Chair: Jin-fu Xu, MD Shanghai Pulmonary Hospital, Shanghai, China
More Information
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Responsible Party: Jin-Fu Xu, Chief of Department of Pulmonary and Critical Care Medicine, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT04509661    
Other Study ID Numbers: 20200413
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: April 2020

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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
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents