Combined @entity10453 and XXXX in the treatment of @entity1030 : a randomised controlled trial.

@entity1 @entity10453 @entity245 @entity701 @entity1030 @entity2263 @entity5023 @entity2981 @entity288
BACKGROUND: Inhaled long-acting @entity2263 agonists improve lung function and health status in symptomatic @entity1030 ( @entity1030 ), whereas inhaled @entity288 reduce the frequency of acute episodes of symptom exacerbation and @entity245 in health status. We postulated that a combination of these treatments would be better than each component used alone. METHODS: 1465 @entity1 with @entity1030 were recruited from outpatient departments in 25 countries. They were treated in a randomised, double-blind, parallel-group, placebo-controlled study with either 50 microg @entity10453 twice daily (n=372), 500 microg @entity5023 twice daily (n=374), 50 microg @entity10453 and 500 microg @entity5023 twice daily (n=358), or placebo (n=361) for 12 months. The primary outcome was the pretreatment forced expiratory volume in 1s (FEV1) after 12 months treatment' and after @entity1 had abstained from all bronchodilators for at least 6h and from study medication for at least 12h. Secondary outcomes were other lung function measurements, symptoms and rescue treatment use, the number of exacerbations, @entity1 withdrawals, and disease-specific health status. We assessed adverse events, serum @entity701 concentrations, skin @entity2981 , and electrocardiograms. Analysis was as predefined in the study protocol. FINDINGS: All active treatments improved lung function, symptoms, and health status and reduced use of rescue medication and frequency of exacerbations. Combination therapy improved pretreatment FEV1 significantly more than did placebo (treatment difference 133 mL, 95% CI 105-161, p<0.0001), @entity10453 (73 mL, 46-101, p<0.0001), or @entity5023 alone (95 mL, 67-122, p<0.0001). Combination treatment produced a clinically significant improvement in health status and the greatest reduction in daily symptoms. All treatments were well tolerated with no difference in the frequency of adverse events, @entity2981 , or clinically significant falls in serum @entity701 concentration. INTERPRETATION: Because inhaled long-acting @entity2263 agonists and corticosteroid combination treatment produces better control of symptoms and lung function, with no greater risk of side-effects than that with use of either component alone, this combination treatment should be considered for @entity1 with @entity1030 .
