Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| night symptoms; | — |
Countries
China