A randomized, double-blind, double-dummy crossover study on 42 asthmatics was carried out to compare the single dose effects of salbutamol administered from the widely used metered dose inhaler and a breath operated system (Diskhaler). The bronchodilator response (change in forced expiratory volume in the first second) was almost identical for the two systems. The Diskhaler system however, since it is breath operated, obviates the need for hand-breath coordination.
In this large retrospective pharmacy database analysis, patients using AirFluSal Forspiro were more likely to persist with treatment compared with those using Seretide Diskus as demonstrated by the overall survival experience of the 2 populations (12-month study period). These new data provide a basis for further research to better understand persistence behavior and to develop strategies to address poor persistence.
Mometasone furoate as a nasal spray is an effective treatment for seasonal allergic rhinitis (SAR). An aqueous mometasone nasal spray containing the same active substance and excipients as the originator product (reference mometasone) has been developed. This study was designed to establish therapeutic equivalence of test mometasone to reference mometasone and superiority over placebo for the treatment of SAR in adults. In this multicenter, randomized, double-blind, placebo- and active-controlled, fixed-dose study, patients aged ≥18 years with SAR were randomized 2:2:1 to reference mometasone, test mometasone, or placebo for 28 days. Patients recorded nasal and ocular symptoms daily. The primary end point was change from baseline in the pooled 24-hour reflective total nasal symptom score (rTNSS). Safety and tolerability included evaluation by adverse events (AEs), physical (including nasal) examinations, vital signs assessments, laboratory evaluations, and change in concomitant medications. Four hundred two patients received reference mometasone (n = 156), test mometasone (n = 163), or placebo (n = 83). The intent-to-treat population (ITT) comprised 399 patients, and the per-protocol (PP) population comprised 327 patients. The 95% confidence intervals for the treatment difference (reference minus test mometasone) in change from baseline in pooled 24-hour rTNSS were within prespecified equivalence limits for the PP and ITT populations. Both active treatments showed superiority over placebo (p = 0.0019-0.0087). No significant difference was seen between test mometasone and reference mometasone for any secondary efficacy variables. Treatment-emergent AE incidence was low. No deaths or serious AEs were reported. The test mometasone is efficacious in the treatment of SAR in adults and shows a favorable safety profile. The results indicate that the test mometasone is therapeutically equivalent to the reference mometasone.
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