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

Overview

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.

Full Title of Study: “The Comparisons of the Efficacy and Safety of Inhaled LAMA or LAMA+LABA or ICS+LABA for Patients in COPD C Group With Bronchiectasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 15, 2020

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.

Interventions

  • Drug: Symbicort
    • drug are used for 12 months
  • Drug: Spiriva
    • drug are used for 12 months

Arms, Groups and Cohorts

  • Active Comparator: ICS/LABA Group
    • Symbicort,Inhalation,Individualized medication,12 months.
  • Active Comparator: LAMA Group
    • Tiotropium Bromide,Inhalation,Individualized medication,12 months.
  • Active Comparator: LAMA+LABA Group
    • Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.

Clinical Trial Outcome Measures

Primary Measures

  • Acute exacerbation
    • Time Frame: 12 months
    • The times of acute exacerbation during the trial.

Secondary Measures

  • Number of patients with adverse events
    • Time Frame: 12 months
    • All of the adverse events occurred in the processing of the trial,especially the prevalence of pneumonia.
  • FEV1
    • Time Frame: 12 months
    • Forced Expiratory Volume in one second
  • FVC
    • Time Frame: 12 months
    • Forced Vital Capacity
  • FEV1/FVC
    • Time Frame: 12 months
    • Pulmonary function test
  • SGRQ
    • Time Frame: 12 months
    • St. George’s Respiratory Questionnaire
  • LCQ
    • Time Frame: 12 months
    • The Leicester Cough Questionnaire
  • CAT
    • Time Frame: 12 months
    • COPD Assessment Test
  • mMRC
    • Time Frame: 12 months
    • Modified Medical Research Council Dyspnea Scale

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Pulmonary Hospital, Shanghai, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin-Fu Xu, Department of Respiratory Medicine – Shanghai Pulmonary Hospital, Shanghai, China
  • Overall Official(s)
    • Jin-Fu Xu, Principal Investigator, Shanghai Pulmonary Hospital , Tongji University

Citations Reporting on Results

Oba Y, Lone NA. Comparative efficacy of inhaled corticosteroid and long-acting beta agonist combinations in preventing COPD exacerbations: a Bayesian network meta-analysis. Int J Chron Obstruct Pulmon Dis. 2014 May 12;9:469-79. doi: 10.2147/COPD.S48492. eCollection 2014. Review.

Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev. 2014 Mar 26;(3):CD010844. doi: 10.1002/14651858.CD010844.pub2. Review.

Manoharan A, Short PM, Anderson WJ, Lipworth BJ. Impact of long-acting bronchodilators and exposure to inhaled corticosteroids on mortality in COPD: a real-life retrospective cohort study. Lung. 2014 Oct;192(5):649-52. doi: 10.1007/s00408-014-9611-8. Epub 2014 Jun 22.

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