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 Information
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
Administrative Informations
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