Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China (Tie-COPD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Boehringer Ingelheim Int'l Trading (Shanghai) Co., Ltd
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
Nanshan Zhong, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01455129
First received: September 21, 2011
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Tiotropium
Drug: placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • difference of trough FEV1 at 24 months from baseline [ Time Frame: at 24 months ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 800
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tiotropium group
18 mcg tiotropium, once daily, inhaled by HandiHaler
Drug: Tiotropium
18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months
Other Name: Spiriva
Placebo Comparator: placebo group
matching placebo, once daily, inhaled by HandiHaler
Drug: placebo
placebo, once daily, inhaled by HandiHaler

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455129

Locations
China, Beijing
Beijing Chao-Yang Hospital
Beijing, Beijing, China, 100016
China, Chongqing
Xinqiao Hospital
Chongqing, Chongqing, China, 630037
China, Guangdong
The First People's Hospital of Foshan
Foshan, Guangdong, China, 528000
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510120
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Guangzhou Panyu Center Hospital
Guangzhou, Guangdong, China, 511400
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
The Third Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China, 510150
Liwan Hospital,Guangzhou Medical College
Guangzhou, Guangdong, China, 510150
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510630
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, China, 510317
The Second Hospital of Liwan,Guangzhou
Guangzhou, Guangdong, China, 510180
Huizhou First Hospital
Huizhou, Guangdong, China, 516001
Shaoguan Iron and Steel Group Company limited Hospital
Shaoguan, Guangdong, China, 512032
The First People's Hospital of Shaoguan
Shaoguan, Guangdong, China, 512000
Wengyuan County People's Hospital
Shaoguan, Guangdong, China, 2875303
Shenzhen Sixth People's Hospital
Shenzhen, Guangdong, China, 518052
Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China, 524001
The second people's Hospital,Zhanjiang
Zhanjiang, Guangdong, China, 524000
China, Guizhou
Guizhou People's Hospital
Guiyang, Guizhou, China, 550002
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, China, 550000
China, Hainan
Hainan Provincial People's Hospital
Haikou, Hainan, China, 570311
China, Henan
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
China, Hubei
Tongji Hospital,Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
China, Hunan
The Second People's Hospital of Hunan Province
Changsha, Hunan, China, 410005
Chenzhou No.1 people's Hopital
Chenzhou, Hunan, China, 423000
China, Shanghai
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200031
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Boehringer Ingelheim Int'l Trading (Shanghai) Co., Ltd
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Investigators
Principal Investigator: Nanshan Zhong, Professor The First Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Pixin Ran, Professor The First Affiliated Hospital of Guangzhou Medical University
  More Information

No publications provided

Responsible Party: Nanshan Zhong, Professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01455129     History of Changes
Other Study ID Numbers: 205.467
Study First Received: September 21, 2011
Last Updated: November 4, 2013
Health Authority: China: Ethics Committee

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
chronic obstructive pulmonary disease
COPD
COPD exacerbation
treatment
tiotropium
anticholinergic
acute exacerbation of COPD (AECOPD)

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014