Chronic Obstructive Pulmonary Disease
Conditions
Keywords
chronic obstructive pulmonary disease, COPD, COPD exacerbation, treatment, tiotropium, anticholinergic, acute exacerbation of COPD (AECOPD)
Brief summary
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.
Interventions
DRUGTiotropium
18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months
DRUGplacebo
placebo, once daily, inhaled by HandiHaler
Sponsors
Boehringer Ingelheim
Rundo International Pharmaceutical Research & Development Co.,Ltd.
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age: 40-85 yrs, both male and female, with or without smoking history, receiving treatment in community hospitals or outpatient department in general hospitals * GOLD Stage I-II COPD: FEV1/FVC\<70% and FEV1≥50% predicted, measured 20min after 400μg salbutamol inhalation * With stable COPD: no COPD exacerbation during the latest 4 weeks prior to the recruitment * With capability of communicating via oral conversation or written documents and signing informed consent * With agreement to receive and are capable of participating in study related auxiliary examinations * Capability of proper use of HandiHaler
Exclusion criteria
* Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study * Patients with clinically significant abnormal baseline haematology, blood biochemistry or urinary analysis, if the abnormality defines a significant disease as defined in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| difference of trough FEV1 at 24 months from baseline | at 24 months |
Secondary
| Measure | Time frame |
|---|---|
| trough (pre-bronchodilator) FEV1 at 1, 6, 12 and 18 months | at 1, 6, 12 and 18 months |
| quality of life (CAT and CCQ) | at 1, 3, 6, 9, 12, 15, 18 and 24 months |
| symptom scores (mMRC dyspnoea scale) | at 1, 3, 6, 9, 12, 15, 18 and 24 months |
| time to first COPD exacerbation | 24 months |
| number of COPD exacerbation | 24 months |
| severity of COPD exacerbation | 24 months |
| Application of rescue medications | 24 months |
| drop-out rate | 24 months |
| adverse events | 24 months |
| difference of peak FEV1 at 24 months from baseline | at 24 months |
| Yearly rate of decline in trough FEV1 from 1 month until completion of double-blind treatment | 24 months |
| Yearly rate of decline in peak FEV1 from 1 month until completion of double-blind treatment | 24 months |
| Yearly rate of decline in trough FVC from 1 month until completion of double-blind treatment | 24 months |
| Yearly rate of decline in peak FVC from 1 month until completion of double-blind treatment | 24 months |
| Yearly rate of decline in trough FEV1/FVC from 1 month until completion of double-blind treatment | 24 months |
| Yearly rate of decline in peak FEV1/FVC from 1 month until completion of double-blind treatment | 24 months |
| interval of COPD exacerbation | 24 months |
| duration of COPD exacerbation | 24 months |
| peak (post-bronchodilator) FEV1 at 1, 6, 12 and 18 months | at 1, 6, 12 and 18 months |
Countries
China
Outcome results
None listed