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Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD

Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD: a Randomised, Open-label, Multicentre Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17012417
Enrollment
Unknown
Registered
2017-08-19
Start date
2017-09-01
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic obstructive pulmonary disease

Interventions

Experimenta:Tiotropium
Active Comparator:Formoterol

Sponsors

Huashan hospital, Fudan university
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Aged 18 to 80 years; Group A/B stable COPD according to the new GOLD2017 criteria; Patients must be able to understand and be willing to sign a written informed consent document.

Exclusion criteria

Exclusion criteria: 1. Acute exacerbation of COPD within one month prior to study entry; 2. Patients with significant diseases other than COPD; 3. A diagnosis of asthma, cystic fibrosis, bronchiectasis, or other lung diseases; 4. Patients with tachyarrhythmia or other serious heart diseases; 5. Patients with serious liver diseases; 6. Patients with serious kidney diseases; 7. Patients with serious hematological diseases; 8. Patients with other serious illnesses; 9. Patients with mental illnesses; 10. Patients with acute gastrointestinal hemorrhage within three month prior to study entry; 11. Patients with glaucoma; 12. Women in gestational and lactational period; 13. Patients participated in other clinical trials within three month prior to study entry; 14. Allergies or multiple drug allergies; 15. The staff and their family members in Huashan hospital.

Design outcomes

Primary

MeasureTime frame
a post-bronchodilator forced expiratory volume in one second;

Secondary

MeasureTime frame
the frequency of COPD exacerbation;other lung function parameters(%FEV1, FEV1/FVC);Clinical COPD Questionnaire score;modified Medical Research Council score;COPD Assessment Test score;

Countries

China

Contacts

Public ContactShengqing Li

Huashan hospital, Fudan university

shengqingli@hotmail.com+86 021 52887072

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026