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

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ClinicalTrials.gov Identifier: NCT01455129
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : August 11, 2016
Sponsor:
Collaborators:
Boehringer Ingelheim
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
Nanshan Zhong, 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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Tiotropium Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 841 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2011
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. difference of trough FEV1 at 24 months from baseline [ Time Frame: at 24 months ]

Secondary Outcome Measures :
  1. difference of peak FEV1 at 24 months from baseline [ Time Frame: at 24 months ]
  2. trough (pre-bronchodilator) FEV1 at 1, 6, 12 and 18 months [ Time Frame: at 1, 6, 12 and 18 months ]
  3. quality of life (CAT and CCQ) [ Time Frame: at 1, 3, 6, 9, 12, 15, 18 and 24 months ]
  4. symptom scores (mMRC dyspnoea scale) [ Time Frame: at 1, 3, 6, 9, 12, 15, 18 and 24 months ]
  5. time to first COPD exacerbation [ Time Frame: 24 months ]
  6. number of COPD exacerbation [ Time Frame: 24 months ]
  7. severity of COPD exacerbation [ Time Frame: 24 months ]
  8. Application of rescue medications [ Time Frame: 24 months ]
  9. drop-out rate [ Time Frame: 24 months ]
  10. adverse events [ Time Frame: 24 months ]
  11. peak (post-bronchodilator) FEV1 at 1, 6, 12 and 18 months [ Time Frame: at 1, 6, 12 and 18 months ]
  12. Yearly rate of decline in trough FEV1 from 1 month until completion of double-blind treatment [ Time Frame: 24 months ]
  13. Yearly rate of decline in peak FEV1 from 1 month until completion of double-blind treatment [ Time Frame: 24 months ]
  14. Yearly rate of decline in trough FVC from 1 month until completion of double-blind treatment [ Time Frame: 24 months ]
  15. Yearly rate of decline in peak FVC from 1 month until completion of double-blind treatment [ Time Frame: 24 months ]
  16. Yearly rate of decline in trough FEV1/FVC from 1 month until completion of double-blind treatment [ Time Frame: 24 months ]
  17. Yearly rate of decline in peak FEV1/FVC from 1 month until completion of double-blind treatment [ Time Frame: 24 months ]
  18. interval of COPD exacerbation [ Time Frame: 24 months ]
  19. duration of COPD exacerbation [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455129


Locations
Show Show 25 study locations
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Boehringer Ingelheim
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nanshan Zhong, Professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01455129    
Other Study ID Numbers: 205.467
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Keywords provided by Nanshan Zhong, 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:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action