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Chronic Obstructive Pulmonary DiseasePhase 4Tie-COPDNCT01455129

Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China

A Phase 4 study testing Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Tiotropium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
841 participants
Where
25 sitesChina
Study dates
Nov 2011to Aug 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality, 100016

  • The Second People's Hospital of Hunan Province

    Changsha, Hunan, 410005

  • Chenzhou No.1 people's Hopital

    Chenzhou, Hunan, 423000

  • Xinqiao Hospital

    Chongqing, Chongqing Municipality, 630037

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong, 510120

  • Liwan Hospital,Guangzhou Medical College

    Guangzhou, Guangdong, 510150

  • The Third Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong, 510150

  • Guangdong No.2 Provincial People's Hospital

    Guangzhou, Guangdong, 510317

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510630

  • Guangzhou Panyu Center Hospital

    Guangzhou, Guangdong, 511400

  • The Affiliated Hospital of Guiyang Medical College

    Guiyang, Guizhou, 550000

  • Guizhou People's Hospital

    Guiyang, Guizhou, 550002

  • Huizhou First Hospital

    Huizhou, Guangdong, 516001

  • Shanghai Xuhui District Central Hospital

    Shanghai, Shanghai Municipality, 200031

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200031

  • Wengyuan County People's Hospital

    Shaoguan, Guangdong, 2875303

  • The First People's Hospital of Shaoguan

    Shaoguan, Guangdong, 512000

  • Shaoguan Iron and Steel Group Company limited Hospital

    Shaoguan, Guangdong, 512032

  • Shenzhen Sixth People's Hospital

    Shenzhen, Guangdong, 518052

  • Tongji Hospital,Tongji Medical College of HUST

    Wuhan, Hubei, 430030

  • The second people's Hospital,Zhanjiang

    Zhanjiang, Guangdong, 524000

  • Affiliated Hospital of Guangdong Medical College

    Zhanjiang, Guangdong, 524001

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

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

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.

Being tested
Tiotropium, placebo
Keywords
chronic obstructive pulmonary disease, COPD, COPD exacerbation, treatment, tiotropium, anticholinergic, acute exacerbation of COPD (AECOPD)
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TiotropiumDrug

    Also called Spiriva

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

  • placeboDrug

    placebo, once daily, inhaled by HandiHaler

Study groups in NCT01455129
Study groupRoleWhat they receive
tiotropium groupActive comparator18 mcg tiotropium, once daily, inhaled by HandiHaler
Receives: Drug: Tiotropium
placebo groupPlacebo comparatormatching placebo, once daily, inhaled by HandiHaler
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. difference of trough FEV1 at 24 months from baseline

    Measured: at 24 months

Secondary outcomes (19)

  1. difference of peak FEV1 at 24 months from baseline

    Measured: at 24 months

  2. trough (pre-bronchodilator) FEV1 at 1, 6, 12 and 18 months

    Measured: at 1, 6, 12 and 18 months

  3. quality of life (CAT and CCQ)

    Measured: at 1, 3, 6, 9, 12, 15, 18 and 24 months

  4. symptom scores (mMRC dyspnoea scale)

    Measured: at 1, 3, 6, 9, 12, 15, 18 and 24 months

  5. time to first COPD exacerbation

    Measured: 24 months

  6. number of COPD exacerbation

    Measured: 24 months

  7. severity of COPD exacerbation

    Measured: 24 months

  8. Application of rescue medications

    Measured: 24 months

  9. drop-out rate

    Measured: 24 months

  10. adverse events

    Measured: 24 months

  11. peak (post-bronchodilator) FEV1 at 1, 6, 12 and 18 months

    Measured: at 1, 6, 12 and 18 months

  12. Yearly rate of decline in trough FEV1 from 1 month until completion of double-blind treatment

    Measured: 24 months

  13. Yearly rate of decline in peak FEV1 from 1 month until completion of double-blind treatment

    Measured: 24 months

  14. Yearly rate of decline in trough FVC from 1 month until completion of double-blind treatment

    Measured: 24 months

  15. Yearly rate of decline in peak FVC from 1 month until completion of double-blind treatment

    Measured: 24 months

  16. Yearly rate of decline in trough FEV1/FVC from 1 month until completion of double-blind treatment

    Measured: 24 months

  17. Yearly rate of decline in peak FEV1/FVC from 1 month until completion of double-blind treatment

    Measured: 24 months

  18. interval of COPD exacerbation

    Measured: 24 months

  19. duration of COPD exacerbation

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
841 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01455129
Sponsor's protocol ID
205.467
Acronym
Tie-COPD
Status last verified
Aug 2016
First submitted
21 Sep 2011
Last updated
11 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38199288

  • 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.

    PubMed 28877027

  • 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.

    PubMed 24549160

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

difference of trough FEV1 at 24 months from baseline (time frame: at 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01455129, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.

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