COPD, Bronchiectasis
Conditions
Keywords
LAMA,ICS+LABA,LAMA+LABA
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.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute exacerbation | 12 months | The times of acute exacerbation during the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| FEV1/FVC | 12 months | Pulmonary function test |
| SGRQ | 12 months | St. George's Respiratory Questionnaire |
| LCQ | 12 months | The Leicester Cough Questionnaire |
| CAT | 12 months | COPD Assessment Test |
| mMRC | 12 months | Modified Medical Research Council Dyspnea Scale |
Countries
China
Outcome results
None listed