HZA106837 was of variable treatment duration (from a minimum of 24 weeks to a maximum of 76 weeks with the majority of patients treated for at least 52 weeks). In HZA106837 patients were randomised to receive either fluticasone furoate/vilanterol 92/22 micrograms [n=1009] or FF 92 micrograms [n=1010] both administered once daily. In HZA106837 the primary endpoint was the time to first severe asthma exacerbation. A severe asthma exacerbation was defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Adjusted mean change from baseline in trough FEV 1 was also evaluated as a secondary endpoint.
Avamys was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients. The first four studies looked at Avamys used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis (hay fever), while the fourth lasted four weeks and involved 302 patients with perennial (non-seasonal) allergies, such as allergies to animals. The other two studies were carried out in children aged between two and 11 years: the first involved 558 children with perennial allergic rhinitis and the second involved 554 children with seasonal allergic rhinitis.
Fluticasone propionate is a highly selective agonist at the glucocorticoid receptor with negligible activity at androgen , estrogen , or mineralocorticoid receptors , thereby producing anti-inflammatory and vasoconstriction effects. It has been shown to have a wide range of inhibitory effects on multiple cell types (. mast cell , eosinophil , neutrophil , macrophages , and lymphocytes ) and mediators (. histamine , eicosanoids , leukotrienes , and cytokines ) involved in inflammation . Fluticasone propionate is stated to exert a topical effect on the lungs without significant systemic effects at usual doses, due to its low systemic bioavailability .