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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COPD, Bronchiectasis

Intervention / Treatment
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* Drug: Symbicort
* Drug: Spiriva


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICS/LABA Group<br>Symbicort，Inhalation，Individualized medication，12 months. | Drug: Symbicort<br>* drug are used for 12 months<br>* Other names: Budesonide/Formoterol;|
| Active Comparator: LAMA Group<br>Tiotropium Bromide，Inhalation,Individualized medication，12 months. | Drug: Spiriva<br>* drug are used for 12 months<br>* Other names: Tiotropium Bromide;|
| Active Comparator: LAMA+LABA Group<br>Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months. | Drug: Symbicort<br>* drug are used for 12 months<br>* Other names: Budesonide/Formoterol;Drug: Spiriva<br>* drug are used for 12 months<br>* Other names: Tiotropium Bromide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute exacerbation | The times of acute exacerbation during the trial. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LAMA,ICS+LABA,LAMA+LABA