Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis
Primary Purpose
COPD, Bronchiectasis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Symbicort
Spiriva
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring LAMA,ICS+LABA,LAMA+LABA
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.
Sites / Locations
- Shanghai Pulmonary Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
ICS/LABA Group
LAMA Group
LAMA+LABA Group
Arm Description
Symbicort,Inhalation,Individualized medication,12 months.
Tiotropium Bromide,Inhalation,Individualized medication,12 months.
Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.
Outcomes
Primary Outcome Measures
Acute exacerbation
The times of acute exacerbation during the trial.
Secondary Outcome Measures
Number of patients with adverse events
All of the adverse events occurred in the processing of the trial,especially the prevalence of pneumonia.
FEV1
Forced Expiratory Volume in one second
FVC
Forced Vital Capacity
FEV1/FVC
Pulmonary function test
SGRQ
St. George's Respiratory Questionnaire
LCQ
The Leicester Cough Questionnaire
CAT
COPD Assessment Test
mMRC
Modified Medical Research Council Dyspnea Scale
Full Information
NCT ID
NCT02546297
First Posted
July 22, 2015
Last Updated
July 29, 2019
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
1. Study Identification
Unique Protocol Identification Number
NCT02546297
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
September 15, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Bronchiectasis
Keywords
LAMA,ICS+LABA,LAMA+LABA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICS/LABA Group
Arm Type
Active Comparator
Arm Description
Symbicort,Inhalation,Individualized medication,12 months.
Arm Title
LAMA Group
Arm Type
Active Comparator
Arm Description
Tiotropium Bromide,Inhalation,Individualized medication,12 months.
Arm Title
LAMA+LABA Group
Arm Type
Active Comparator
Arm Description
Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.
Intervention Type
Drug
Intervention Name(s)
Symbicort
Other Intervention Name(s)
Budesonide/Formoterol
Intervention Description
drug are used for 12 months
Intervention Type
Drug
Intervention Name(s)
Spiriva
Other Intervention Name(s)
Tiotropium Bromide
Intervention Description
drug are used for 12 months
Primary Outcome Measure Information:
Title
Acute exacerbation
Description
The times of acute exacerbation during the trial.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of patients with adverse events
Description
All of the adverse events occurred in the processing of the trial,especially the prevalence of pneumonia.
Time Frame
12 months
Title
FEV1
Description
Forced Expiratory Volume in one second
Time Frame
12 months
Title
FVC
Description
Forced Vital Capacity
Time Frame
12 months
Title
FEV1/FVC
Description
Pulmonary function test
Time Frame
12 months
Title
SGRQ
Description
St. George's Respiratory Questionnaire
Time Frame
12 months
Title
LCQ
Description
The Leicester Cough Questionnaire
Time Frame
12 months
Title
CAT
Description
COPD Assessment Test
Time Frame
12 months
Title
mMRC
Description
Modified Medical Research Council Dyspnea Scale
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Fu Xu
Organizational Affiliation
Shanghai Pulmonary Hospital , Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24872685
Citation
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.
Results Reference
result
PubMed Identifier
24671923
Citation
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.
Results Reference
result
PubMed Identifier
24952426
Citation
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.
Results Reference
result
Learn more about this trial
Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis
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