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

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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

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Actue exacerbation

Secondary Outcome

 modified Medical Research Council score

Condition

Bronchiectasis Adult

Intervention

LABA/LAMA or Placebo inhalation

Study Arms / Comparison Groups

 Experimental group
Description:  Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

200

Start Date

September 1, 2020

Completion Date

June 1, 2024

Primary Completion Date

June 1, 2024

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jin-fu Xu, MD, +86 13321922898, [email protected]

Administrative Informations

NCT ID

NCT04509661

Organization ID

20200413

Responsible Party

Principal Investigator

Study Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Study Sponsor

Jin-fu Xu, MD, Study Chair, Shanghai Pulmonary Hospital, Shanghai, China

Verification Date

April 2020