the efficacy and safety of salmeterol/fluticasone propionate vs atropium/albuterol in patients copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: to determine the efficacy and safety of salmeterol/fluticasone propionate 50/500ug bid vs ipratropium/albuterol 36/206ug qid in chinese patients with moderate-to-severe chronic obstructive pulmonary disease (copd).

* this is a 12-week, multicentre,randomized,open-label,active-controlled, paralleled-group study. * chinese patients aged ≥40 years with moderate-to-severe copd are eligible for this study. 1. if satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized salbutamol. 2. patients record daily severity ratings for daytime symptoms of shortness of breath, tiredness, activity limitation, frustration with symptoms, and night-time sleep symptoms on daily cards. 3. each symptom is rated using 0-100 visual analog scal (vas). for overall assessment of daytime symptoms, a combined symptom score is obtained by adding vas scores for shortness of breath, tiredness, activity limitation, frustration with symptoms. 4. patients are required to be symptomatic as demonstrated by a combined daytime symptom score of 120 on at least 4 of the 7 days prior to randomization. 1. eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks. 1. inhaled salmeterol/fluticasone propionate 50/500ug twice daily or inhaled ib/alb 36/206ug qid. 2. salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks. 2. a follow-up visit will be conducted 2 weeks after completion of treatment/early withdrawal to assess for any adverse effects after discontinuing study treatment.

Eligibility criteria:
inclusion criteria: * chinese male or female outpatients aged 40 to 79 years, inclusive * patients with an established diagnosis of copd, defined as gold guideline postbronchodilation fev1/fvc ratio of \<70%, and postbronchodilation fev1% predicted ranged from ≥25 to ≤70. * a cigarette smoking history of 10 pack-years * use of oral theophylline, or any other inhaled medications other than laba, lama, or ics for≥30 days (e.g. saba, sama) * patients who are able to use accuhaler device and relief medication * patients willing to give informed consent to participate in the study and comply to study protocol * eligible female on child-bearing potentia exclusion criteria: * patients with concurrent respiratory disorders (e.g. asthma) other than copd * patients with a requirement for regular or long term oxygen therapy (\>12h/d) * patients who used inhaled or oral steroids within 30 days of screening * patients who had a respiratory tract infection requiring antibiotics within 14 days of screening * patients with a moderate-to-severe copd exacerbation within 30 days of screening * patients with any significant medical condition or disease that would place patients at risk or interfere with the study evaluation. * patients who used some inhibitory agents (e.g. b blockers) within 14 days of screening * female patients who is pregnant or may be pregnant in the study duration

Keywords: copd seretide combivent effect and safety twelve weeks