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

Shanghai Pulmonary Hospital, Shanghai, China

Status and phase: Unknown; Phase 4

Conditions: Bronchiectasis; COPD

Treatments: Drug: Spiriva; Drug: Symbicort

Study type: Interventional

Funder types: Other

Identifiers

NCT02546297

20150717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

ICS/LABA Group

Active Comparator group

Description:

Symbicort，Inhalation，Individualized medication，12 months.

Treatment:

Drug: Symbicort

LAMA Group

Active Comparator group

Description:

Tiotropium Bromide，Inhalation,Individualized medication，12 months.

Treatment:

Drug: Spiriva

LAMA+LABA Group

Active Comparator group

Description:

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

Treatment:

Drug: Symbicort

Drug: Spiriva