Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China

NCT01455129 | Completed Phase 4

• 1 other identifier: 205.467
• Study Type: interventional
• Target: 841
• Locations: 1 country
• Sites: 25

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; COPD; COPD exacerbation; treatment; tiotropium; anticholinergic; acute exacerbation of COPD (AECOPD)

Outcome Measures

Primary Outcomes (1)

• difference of trough FEV1 at 24 months from baseline

  at 24 months

Secondary Outcomes (19)

• 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

Study Arms (2)

tiotropium group

ACTIVE COMPARATOR

18 mcg tiotropium, once daily, inhaled by HandiHaler

Drug: Tiotropium

placebo group

PLACEBO COMPARATOR

matching placebo, once daily, inhaled by HandiHaler

Drug: placebo

Interventions

Tiotropium DRUG

18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months

Also known as: Spiriva

tiotropium group

placebo DRUG

placebo, once daily, inhaled by HandiHaler

placebo group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• Boehringer Ingelheim: collaborator
• Rundo International Pharmaceutical Research & Development Co.,Ltd.: collaborator

Study Sites (25)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100016, China

Location

Xinqiao Hospital

Chongqing, Chongqing Municipality, 630037, China

Location

The First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

Location

Liwan Hospital,Guangzhou Medical College

Guangzhou, Guangdong, 510150, China

Location

The Third Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510150, China

Location

Guangdong No.2 Provincial People's Hospital

Guangzhou, Guangdong, 510317, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

Guangzhou Panyu Center Hospital

Guangzhou, Guangdong, 511400, China

Location

Huizhou First Hospital

Huizhou, Guangdong, 516001, China

Location

Wengyuan County People's Hospital

Shaoguan, Guangdong, 2875303, China

Location

The First People's Hospital of Shaoguan

Shaoguan, Guangdong, 512000, China

Location

Shaoguan Iron and Steel Group Company limited Hospital

Shaoguan, Guangdong, 512032, China

Location

Shenzhen Sixth People's Hospital

Shenzhen, Guangdong, 518052, China

Location

The second people's Hospital,Zhanjiang

Zhanjiang, Guangdong, 524000, China

Location

Affiliated Hospital of Guangdong Medical College

Zhanjiang, Guangdong, 524001, China

Location

The Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, 550000, China

Location

Guizhou People's Hospital

Guiyang, Guizhou, 550002, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Tongji Hospital,Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

Location

The Second People's Hospital of Hunan Province

Changsha, Hunan, 410005, China

Location

Chenzhou No.1 people's Hopital

Chenzhou, Hunan, 423000, China

Location

Shanghai Xuhui District Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (3)

• Wu F, Dai C, Zhou Y, Deng Z, Wang Z, Li X, Chen S, Guan W, Zhong N, Ran P. Tiotropium reduces clinically important deterioration in patients with mild-to-moderate chronic obstructive pulmonary disease: A post hoc analysis of the Tie-COPD study. Respir Med. 2024 Feb;222:107527. doi: 10.1016/j.rmed.2024.107527. Epub 2024 Jan 8.

  PMID: 38199288 DERIVED

• Zhou Y, Zhong NS, Li X, Chen S, Zheng J, Zhao D, Yao W, Zhi R, Wei L, He B, Zhang X, Yang C, Li Y, Li F, Du J, Gui J, Hu B, Bai C, Huang P, Chen G, Xu Y, Wang C, Liang B, Li Y, Hu G, Tan H, Ye X, Ma X, Chen Y, Hu X, Tian J, Zhu X, Shi Z, Du X, Li M, Liu S, Yu R, Zhao J, Ma Q, Xie C, Li X, Chen T, Lin Y, Zeng L, Ye C, Ye W, Luo X, Zeng L, Yu S, Guan WJ, Ran P. Tiotropium in Early-Stage Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Sep 7;377(10):923-935. doi: 10.1056/NEJMoa1700228.

  PMID: 28877027 DERIVED

• Li X, Zhou Y, Chen S, Zheng J, Zhong N, Ran P. Early intervention with tiotropium in Chinese patients with GOLD stages I-II chronic obstructive pulmonary disease (Tie-COPD): study protocol for a multicentre, double-blinded, randomised, controlled trial. BMJ Open. 2014 Feb 18;4(2):e003991. doi: 10.1136/bmjopen-2013-003991.

  PMID: 24549160 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Nanshan Zhong, Professor

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Pixin Ran, Professor

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: October 19, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

CN (25)