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Efficacy of Tiotropium on severe COPD patient who have night symptoms

Efficacy of Tiotropium on severe COPD patient who have night symptoms

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15005961
Enrollment
Unknown
Registered
2015-01-11
Start date
2015-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Case series:Tiotropium

Sponsors

Zhongshan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. patients who first diagnosed COPD or previously diagnosed but not regular treatment with FEV1/FVC <70% and FEV1% <50% predicted, 15min after bronchodilator Salbutamol 400ug inhalation; 2. aged 40-80 years old, no gender limitation; 3. patients who having COPD night symptoms(definition: at least 2 followed symptoms appeared in night sleep, and influenced the sleep quality), such as: (1) Cough; (2) Sputum; (3) Chest distress; (4) Wheeze; (5) Breathless; 4. patients know how to use inhalation equipment, and never used long-term bronchodilator within 4 weeks; 5. no COPD exacerbation within 4 weeks; 6. voluntarily participated and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. patients who had acute and/or chronic pulmonary diseases such as asthma which might impair lung function; 2. accepted the systemic glucocorticoid treatment within 1 month; 3. now accepting Tiotropium bromide treatment alone or jointly; 4. patients who now accepting short-term anticholinergics treatment alone or jointly must stop at least 1 week; 5. patients who had COPD exacerbation or used antibiotics within 1 month; 6. be allergic to Tiotropium bromide; 7. patients who had malignant tumor; 8. patients who had active tuberculosis; 9. mental disease or cognitive disorders who couldn't finish questionnaire; 10. patients with Narrow-angleglaucoma, severe BPH and bladder-neck obstruction; 11. patients who attended other clinical trial within 3 months; 12. not suitable for this trial.

Design outcomes

Primary

MeasureTime frame
night symptoms;

Countries

China

Contacts

Public ContactSong Yuanlin
song.yuanlin@zs-hospital.sh.cn+86 15021757762

Outcome results

None listed

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