Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis

Brief Title

Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis

Official Title

The Comparisons of the Efficacy and Safety of Inhaled LAMA or LAMA+LABA or ICS+LABA for Patients in COPD C Group With Bronchiectasis

Brief Summary

      The purpose of this study is to determine which treatment is more effective and safer for the
      patients in COPD C group with bronchiectasis.The research results will help guide physicians
      to select appropriate individualized treatment and hopefully provide some evidence-based
      medicine proofs for revising guide.
    

Detailed Description

      The diagnosis and treatment of COPD and bronchiectasis together seems to be more complicated
      than the diagnosis and treatment of either condition alone. According to the GOLD，there are
      three treatments for patients with COPD in group C: ICS combined with LABA or LAMA alone or
      LABA combined with LAMA. However, it has not yet been demonstrated about which method is more
      effective for the patients with COPD in group C and bronchiectasis.

      This study is designed as a prospective, randomized, case-control trial. Patients are divided
      into three groups, one group inhaled with ICS and LABA (Symbicort), the second group inhaled
      with LAMA (Tiotropium Bromide) and the third group inhaled with LAMA(Tiotropium Bromide) and
      (Symbicort).The course of treatment is 12 months.

      The investigators will also assess other relevant outcomes, including the quality of life
      (QOL) score, pulmonary function test and the incidence of adverse event.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Acute exacerbation

Secondary Outcome

 Number of patients with adverse events

Condition

COPD

Intervention

Symbicort

Study Arms / Comparison Groups

 ICS/LABA Group

Description:  Symbicort，Inhalation，Individualized medication，12 months.

Publications

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

Recruitment Status

Drug

Estimated Enrollment

90

Start Date

September 15, 2017

Completion Date

March 1, 2021

Primary Completion Date

September 15, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients are suitable for inclusion in the study when they are 18 years or older
             diagnosed with COPD C group and bronchiectasis.

        Exclusion Criteria:

          -  active tuberculosis

          -  severe respiratory disease (such as Lung cancer, ARDS, pulmonary encephalopathy,
             respiratory failure)

          -  uncontrollable diabetes

          -  hypersensitivity to any components of ICS/LABA or LAMA.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jin-Fu Xu, , 

Location Countries

China

Location Countries

China

NCT ID

NCT02546297

Organization ID

20150717

Responsible Party

Principal Investigator

Study Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Study Sponsor

Jin-Fu Xu, Principal Investigator, Shanghai Pulmonary Hospital , Tongji University

Verification Date

July 2019