Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, GOLD, formoterol, tiotropium
Brief summary
Chronic obstructive pulmonary disease (COPD) is a disease state characterized by persistent airflow limitation and associated with an accelerated decline in lung function, impaired quality of life, hospitalization, and increased mortality. As a major public health problem, COPD is predicted to rank as the fifth burden of diseases in the world by 2020. Thus, prevention of exacerbations is a important goal in the management of COPD. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Scientific Committee launched a joint project in 1998. Its goals were to raise awareness of COPD and to improve prevention and treatment of COPD patients around the world. In the 2017 GOLD guidelines, inhaled long-acting bronchodilators, including inhaled long-acting muscarinic antagonists (LAMAs) and inhaled long-acting beta-agonists (LABAs), are recommended for the management of all stable COPD patients. However, it is not known whether LABA or LAMA will be more effective for initial relief of symptoms in patients with GOLD A/B COPD. In this multicenter, randomized study, the investigators evaluate the efficacy of formoterol(LABA) and tiotropium(LAMA) in the treatment of patients with GOLD A/B COPD. The primary endpoint is postbronchodilator FEV1, and the secondary endpoints include the frequency of COPD exacerbation, other lung function parameters, CCQ score and mMRC/CAT score.
Interventions
DRUGTiotropium
inhaled Tiotropium(18μg, qd)
DRUGFormoterol
inhaled formoterol(4.5μg, bid)
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of group A or group B stable COPD. Must be able to inhale Formoterol or Tiotropium.
Exclusion criteria
Asthma. Cystic fibrosis. Bronchiectasis. Lung cancer. Glaucoma. Tachyarrhythmia or other serious heart diseases. Prostatic hyperplasia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postbronchodilator FEV1 | 12 months | a post-bronchodilator forced expiratory volume in one second |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the frequency of COPD exacerbation | 12 months | the frequency of COPD exacerbation |
| other lung function parameters | 12 months | other lung function parameters(%FEV1, FEV1/FVC) |
| CCQ score | 12 months | Clinical COPD Questionnaire score |
| mMRC score | 12 months | modified Medical Research Council score |
| CAT score | 12 months | COPD Assessment Test score |
Countries
China
Contacts
Primary ContactShengqing Li, PhD
Backup ContactPeng Zhang, MD
Outcome results
None listed