OBJECTIVE: @entity10453 / @entity5023 combination (SFC) formulated in a breath-actuated inhaler (BAI) overcomes the co-ordination problem associated with the pressurized-metered dose inhaler (pMDIs). Our aim was to compare the efficacy and the safety of SFC given through the BAI versus the conventional pMDI in moderate-to-severe @entity748 . METHODS: In this randomized, double-blind, double-dummy, prospective, active-controlled, parallel group, multicenter, 12 weeks study, 150 @entity748 were randomized to receive SFC (25/125   mcg) through either BAI or pMDI. The primary efficacy endpoint was mean change in pre-dose morning PEFR value at 12 weeks and the secondary efficacy endpoints included, mean change in FEV1, pre-bronchodilator FVC, pre-dose morning and evening PEFR, symptom scores at 2, 4, 8, and 12 weeks. @entity1 preferences for device and safety were also assessed. RESULTS: At 12 weeks, the mean change in pre-dose morning PEFR in BAI and pMDI groups was 50.72   L/min and 48.82   L/min, respectively (p   <   0.0001; both groups) and the difference between the two groups was not significant. Both the treatment groups showed a statistically significant improvement in secondary endpoints at all-time points compared with baseline. The usability questionnaire assessment results showed that the BAI device was preferred by 75% of @entity1 as compared with 25% preferring pMDI. SFC in both BAI and pMDI devices was found to be safe and well tolerated. CONCLUSION: This is the first study to demonstrate that SFC given through the BAI produces comparable efficacy and safety endpoints as pMDI. Additionally, BAI was the preferred inhaler by @entity1 compared to conventional pMDI.

@entity10453 / XXXX through breath-actuated inhaler versus pMDI: a randomized, double-blind, 12 weeks study.

@entity748 :: ('MESH:D013224', 'Disease') :: ['asthmatics'] @entity1 :: ('9606', 'Species') :: ['patients', 'Patient'] @entity5023 :: ('MESH:C065382', 'Chemical') :: ['fluticasone'] @entity10453 :: ('MESH:C057823', 'Chemical') :: ['Salmeterol']
@entity5023 :: (MESH:C065382,Chemical) :: ['fluticasone']
