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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546297
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2015
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China

Tracking Information
First Submitted Date  ICMJE July 22, 2015
First Posted Date  ICMJE September 10, 2015
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE September 15, 2017
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
Acute exacerbation [ Time Frame: 12 months ]
The times of acute exacerbation during the trial.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
  • 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.
  • Pulmonary function tests [ Time Frame: 12 months ]
    FEV1
  • Pulmonary function tests [ Time Frame: 12 months ]
    FVC
  • Pulmonary function tests [ Time Frame: 12 months ]
    FEV1/FVC
  • quality of life [ Time Frame: 12 months ]
    SGRQ
  • quality of life [ Time Frame: 12 months ]
    LCQ
  • quality of life [ Time Frame: 12 months ]
    CAT
  • quality of life [ Time Frame: 12 months ]
    mMRC
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Bronchiectasis
Intervention  ICMJE
  • Drug: Symbicort
    drug are used for 12 months
    Other Name: Budesonide/Formoterol
  • Drug: Spiriva
    drug are used for 12 months
    Other Name: Tiotropium Bromide
Study Arms  ICMJE
  • Active Comparator: ICS/LABA Group
    Symbicort,Inhalation,Individualized medication,12 months.
    Intervention: Drug: Symbicort
  • Active Comparator: LAMA Group
    Tiotropium Bromide,Inhalation,Individualized medication,12 months.
    Intervention: Drug: Spiriva
  • Active Comparator: LAMA+LABA Group
    Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.
    Interventions:
    • Drug: Symbicort
    • Drug: Spiriva
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 29, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2015)
80
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02546297
Other Study ID Numbers  ICMJE 20150717
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin-Fu Xu, Shanghai Pulmonary Hospital, Shanghai, China
Study Sponsor  ICMJE Shanghai Pulmonary Hospital, Shanghai, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin-Fu Xu Shanghai Pulmonary Hospital , Tongji University
PRS Account Shanghai Pulmonary Hospital, Shanghai, China
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP