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

Phase 4

• Conditions: COPD; Bronchiectasis
• Interventions: Drug: Symbicort; Drug: Spiriva

• Registration Number: NCT02546297
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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 Timeline

• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Study Start: 2017-09-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-08-01
• Primary Completion: 2020-09-15
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LAMA+LABA Group	Symbicort	Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.
LAMA Group	Spiriva	Tiotropium Bromide，Inhalation,Individualized medication，12 months.
ICS/LABA Group	Symbicort	Symbicort，Inhalation，Individualized medication，12 months.
LAMA+LABA Group	Spiriva	Tiotropium Bromide, Symbicort, Inhalation, Individualized medication, 12 months.

Primary Outcome Measures

Name	Time	Method
Acute exacerbation	12 months	The times of acute exacerbation during the trial.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China