Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: placebo
- Registration Number
- NCT01455129
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 841
- 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
- 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 exclusion criteria No. 1
- Patients with clinical diagnosis of lung cancer, bronchiectasis, pneumoconioses, or other single restricted ventilation
- Severe cardiovascular, neural, hepatic, renal and hematologic diseases or malignancies that may interfere with the operation of the study
- Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms, or narrow angle glaucoma
- Patients with known moderate to severe impaired renal function in the opinion of the investigator or creatinine clearance ≤50 ml/min
- Patients with history of asthma, allergic rhinitis, or who have a blood eosinophil count ≥600/mm^3
- Patients with active pulmonary tuberculosis
- Patients with life-threatening pulmonary embolism, α1-antitrypsin deficiency, or cystic fibrosis
- History of pneumonectomy
- COPD exacerbation in 4 weeks prior to the first visit (V0), or hospitalization and/or antibiotic application and/or oral or intravenous glucocorticosteroids application is required during screening stage.
- Treated with one of the trial drugs during the 30 days or 6 half-lives prior to the first visit (V0), with the selection of the longer period
- Long-term oxygen therapy, frequent use of glucocorticosteroids orally or intravenously at unstable doses(i.e. less than six weeks on stable doses) or at doses in excess of the equivalent of 10 mg of prednisone/day, or long-term use of antibiotics
- Pregnancy, lactation or potential of pregnancy
- Planned hospitalization or blood donation during the trial
- Known hypersensitivity or intolerance to trial drugs
- History of chronic alcohol or drug abuse, or any other conditions that may impact compliance
- Involvement in other clinical studies at the same time
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group placebo matching placebo, once daily, inhaled by HandiHaler tiotropium group Tiotropium 18 mcg tiotropium, once daily, inhaled by HandiHaler
- Primary Outcome Measures
Name Time Method difference of trough FEV1 at 24 months from baseline at 24 months
- Secondary Outcome Measures
Name Time Method duration of COPD exacerbation 24 months difference of peak FEV1 at 24 months from baseline at 24 months 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 peak (post-bronchodilator) FEV1 at 1, 6, 12 and 18 months at 1, 6, 12 and 18 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 FVC from 1 month until completion of double-blind treatment 24 months interval of COPD exacerbation 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 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
Trial Locations
- Locations (25)
Guangdong No.2 Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Shaoguan Iron and Steel Group Company limited Hospital
🇨🇳Shaoguan, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Xinqiao Hospital
🇨🇳Chongqing, Chongqing, China
The First People's Hospital of Shaoguan
🇨🇳Shaoguan, Guangdong, China
Guizhou People's Hospital
🇨🇳Guiyang, Guizhou, China
The Third Affiliated Hospital of Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
Guangzhou Panyu Center Hospital
🇨🇳Guangzhou, Guangdong, China
Tongji Hospital,Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
The Second People's Hospital of Hunan Province
🇨🇳Changsha, Hunan, China
Huizhou First Hospital
🇨🇳Huizhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
The First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Liwan Hospital,Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Guangdong, China
Wengyuan County People's Hospital
🇨🇳Shaoguan, Guangdong, China
The second people's Hospital,Zhanjiang
🇨🇳Zhanjiang, Guangdong, China
Affiliated Hospital of Guangdong Medical College
🇨🇳Zhanjiang, Guangdong, China
The Affiliated Hospital of Guiyang Medical College
🇨🇳Guiyang, Guizhou, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Shanghai Xuhui District Central Hospital
🇨🇳Shanghai, Shanghai, China
Chenzhou No.1 people's Hopital
🇨🇳Chenzhou, Hunan, China
Beijing Chao-Yang Hospital
🇨🇳Beijing, Beijing, China
Shenzhen Sixth People's Hospital
🇨🇳Shenzhen, Guangdong, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China