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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2021-03-01

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.

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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.

Conditions

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COPD Bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ICS/LABA Group

Symbicort，Inhalation，Individualized medication，12 months.

Group Type ACTIVE_COMPARATOR

Symbicort

Intervention Type DRUG

drug are used for 12 months

LAMA Group

Tiotropium Bromide，Inhalation,Individualized medication，12 months.

Group Type ACTIVE_COMPARATOR

Spiriva

Intervention Type DRUG

drug are used for 12 months

LAMA+LABA Group

Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.

Group Type ACTIVE_COMPARATOR

Symbicort

Intervention Type DRUG

drug are used for 12 months

Spiriva

Intervention Type DRUG

drug are used for 12 months

Interventions

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Symbicort

drug are used for 12 months

Intervention Type DRUG

Spiriva

drug are used for 12 months

Intervention Type DRUG

Other Intervention Names

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Budesonide/Formoterol Tiotropium Bromide

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No