Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China

Chronic Obstructive Pulmonary Disease Clinical Trial

— Tie-COPD  

Official title:

Early Intervention With Tiotropium （Spiriva） in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomized, Double-blind, Placebo-controlled, Parallel, Multicentre Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455129
• Other study ID #: 205.467
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2011
• Last updated: August 10, 2016
• Start date: November 2011
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 841
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 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, a1-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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium
18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months
• placebo
placebo, once daily, inhaled by HandiHaler

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing	Beijing
China	The Second People's Hospital of Hunan Province	Changsha	Hunan
China	Chenzhou No.1 people's Hopital	Chenzhou	Hunan
China	Xinqiao Hospital	Chongqing	Chongqing
China	The First People's Hospital of Foshan	Foshan	Guangdong
China	Guangdong No.2 Provincial People's Hospital	Guangzhou	Guangdong
China	Guangzhou Panyu Center Hospital	Guangzhou	Guangdong
China	Liwan Hospital,Guangzhou Medical College	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong
China	Guizhou People's Hospital	Guiyang	Guizhou
China	The Affiliated Hospital of Guiyang Medical College	Guiyang	Guizhou
China	Huizhou First Hospital	Huizhou	Guangdong
China	Shanghai Xuhui District Central Hospital	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Shaoguan Iron and Steel Group Company limited Hospital	Shaoguan	Guangdong
China	The First People's Hospital of Shaoguan	Shaoguan	Guangdong
China	Wengyuan County People's Hospital	Shaoguan	Guangdong
China	Shenzhen Sixth People's Hospital	Shenzhen	Guangdong
China	Tongji Hospital,Tongji Medical College of HUST	Wuhan	Hubei
China	Affiliated Hospital of Guangdong Medical College	Zhanjiang	Guangdong
China	The second people's Hospital,Zhanjiang	Zhanjiang	Guangdong
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University	Boehringer Ingelheim, Rundo International Pharmaceutical Research & Development Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of trough FEV1 at 24 months from baseline		at 24 months	No
Secondary	difference of peak FEV1 at 24 months from baseline		at 24 months	No
Secondary	trough (pre-bronchodilator) FEV1 at 1, 6, 12 and 18 months		at 1, 6, 12 and 18 months	No
Secondary	quality of life (CAT and CCQ)		at 1, 3, 6, 9, 12, 15, 18 and 24 months	No
Secondary	symptom scores (mMRC dyspnoea scale)		at 1, 3, 6, 9, 12, 15, 18 and 24 months	No
Secondary	time to first COPD exacerbation		24 months	No
Secondary	number of COPD exacerbation		24 months	No
Secondary	severity of COPD exacerbation		24 months	No
Secondary	Application of rescue medications		24 months	No
Secondary	drop-out rate		24 months	No
Secondary	adverse events		24 months	Yes
Secondary	peak (post-bronchodilator) FEV1 at 1, 6, 12 and 18 months		at 1, 6, 12 and 18 months	No
Secondary	Yearly rate of decline in trough FEV1 from 1 month until completion of double-blind treatment		24 months	No
Secondary	Yearly rate of decline in peak FEV1 from 1 month until completion of double-blind treatment		24 months	No
Secondary	Yearly rate of decline in trough FVC from 1 month until completion of double-blind treatment		24 months	No
Secondary	Yearly rate of decline in peak FVC from 1 month until completion of double-blind treatment		24 months	No
Secondary	Yearly rate of decline in trough FEV1/FVC from 1 month until completion of double-blind treatment		24 months	No
Secondary	Yearly rate of decline in peak FEV1/FVC from 1 month until completion of double-blind treatment		24 months	No
Secondary	interval of COPD exacerbation		24 months	No
Secondary	duration of COPD exacerbation		24 months	No