Chronic obstructive pulmonary disease (COPD) is one of the commonest respiratory diseases. During the early stage of COPD, patients only have mild respiratory symptoms or signs which may lead to under-diagnosis of the disease. Patients may show poor response to treatment at later stages of the disease, associated with higher mortality and incidence of re-hospitalization and disability causing burden for both the families and the society. So far, there is no large-scale clinical trial on long-term intervention with tiotropium bromide (Spiriva) in patients with early stages of COPD (i.e. GOLD Stage I-II COPD or asymptomatic COPD). It would be of great significance for COPD prevention and treatment if the investigators could prove that tiotropium decreases the lung function decline and reverses disease progression in patients with early-stage COPD. The investigators objective is to evaluate the efficacy of long-term intervention with tiotropium in early stage (FEV1 ≥50% predicted) COPD (difference of trough FEV1, number of exacerbations, time to first exacerbation, quality of life, etc) and relevant pharmacoeconomic endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
841
18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months
placebo, once daily, inhaled by HandiHaler
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital
Chongqing, Chongqing Municipality, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Liwan Hospital,Guangzhou Medical College
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Guangzhou Panyu Center Hospital
Guangzhou, Guangdong, China
...and 15 more locations
difference of trough FEV1 at 24 months from baseline
Time frame: at 24 months
difference of peak FEV1 at 24 months from baseline
Time frame: at 24 months
trough (pre-bronchodilator) FEV1 at 1, 6, 12 and 18 months
Time frame: at 1, 6, 12 and 18 months
quality of life (CAT and CCQ)
Time frame: at 1, 3, 6, 9, 12, 15, 18 and 24 months
symptom scores (mMRC dyspnoea scale)
Time frame: at 1, 3, 6, 9, 12, 15, 18 and 24 months
time to first COPD exacerbation
Time frame: 24 months
number of COPD exacerbation
Time frame: 24 months
severity of COPD exacerbation
Time frame: 24 months
Application of rescue medications
Time frame: 24 months
drop-out rate
Time frame: 24 months
adverse events
Time frame: 24 months
peak (post-bronchodilator) FEV1 at 1, 6, 12 and 18 months
Time frame: at 1, 6, 12 and 18 months
Yearly rate of decline in trough FEV1 from 1 month until completion of double-blind treatment
Time frame: 24 months
Yearly rate of decline in peak FEV1 from 1 month until completion of double-blind treatment
Time frame: 24 months
Yearly rate of decline in trough FVC from 1 month until completion of double-blind treatment
Time frame: 24 months
Yearly rate of decline in peak FVC from 1 month until completion of double-blind treatment
Time frame: 24 months
Yearly rate of decline in trough FEV1/FVC from 1 month until completion of double-blind treatment
Time frame: 24 months
Yearly rate of decline in peak FEV1/FVC from 1 month until completion of double-blind treatment
Time frame: 24 months
interval of COPD exacerbation
Time frame: 24 months
duration of COPD exacerbation
Time frame: 24 months
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