Moderate-to-severe COPD
Conditions
Interventions
1:trial group:Salmeterol/Fluticasone Propionate
2:control group : Ipratropium/Albuterol
Sponsors
Fudan University Affiliated Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Chinese male or female outpatients aged 40 to 79 years; 2. Patients with an established diagnosis of COPD, defined as GOLD guideline: Postbronchodilation FEV1/FVC ratio of =25% to <=70%. 3. a cigarette smoking history of 10 pack-years; 4. Use of oral theophylline, or any other inhaled medications other than LABA, LAMA, or ICS for 330 days (e.g. SABA, SAMA); 5. Patients who are able to use Accuhaler device and relief medication; 6. Patients willing to give informed consent to participate in the study and comply to study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with concurrent respiratory disorders (e.g. asthma) other than COPD; 2. Patients with a requirement for regular or long term oxygen therapy (>12h/d); 3. Patients who used inhaled or oral steroids within 30 days of screening; 4. Patients who had a respiratory tract infection requiring antibiotics within 14 days of screening; 5. Patients with a moderate-to-severe COPD exacerbation within 30 days of screening; 6. Patients with any significant medical condition or disease that would place patients at risk or interfere with the study evaluation; 7. Patients who used some inhibitory agents (e.g. b blockers) within 14 days of screening; 8. Female patients who is pregnant or may be pregnant in the study duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pre-broncholidator FEV1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Morning PEF, IC, RV;BODE index;6 hour FEV1 AUC;CC-16 and SPD protein;Overall daytime symptom score;SGRQ scale score; | — |
Countries
China
Contacts
Public ContactChunxue BAI
Outcome results
None listed