Combined fluticasone furoate/vilanterol reduces decline in lung function following inhaled allergen 23？h after dosing in adult asthma: a randomised, controlled trial

In a crossover study of 52 subjects with mild asthma, FF/VI 100/25mcg and FF 100 dosed once-daily in the evening for 28？days were compared with placebo to evaluate their capacity to provide bronchoprotection against the early asthmatic response (EAR) stimulated by an inhaled allergen challenge. Bronchoprotection was assessed by change from post-saline baseline in weighted mean (wm) forced expiratory volume in 1 s (FEV1) for the first 2 h post-allergen challenge, which was on Day 29 (22–23？h post final dose on Day 28). The EAR was also assessed using maximum percent decrease from post-saline baseline and minimum absolute FEV1; the incidence of adverse events was a secondary endpoint.FF/VI 100/25 and FF 100 both provided significant bronchoprotection against the EAR for all endpoints assessed. For wmFEV1 over the first 2？h post-allergen challenge, a 162？mL (95% CI, 87 to 237？mL) difference was observed between placebo and FF 100, while a 145？mL (95% CI, 69 to 222？mL) difference was observed between placebo and FF/VI 100/25 treatment. No difference between active treatments was observed (？17？mL; 95% CI, –91 to 57？mL). Both treatments were well tolerated.FF 100 alone and in combination with VI 25 provides significant bronchoprotection against the EAR in subjects with mild asthma. That this protection is provided at the trough of dosing, i.e. 23？h post last dose, supports the utility of FF 100 and FF/VI 100/25 as viable once-daily therapies.Clinicaltrials.gov identifier: NCT01128569, GSK Study number: HZA113090The link between asthma and atopy is well established [1]. Many asthmatic subjects exhibit an asthmatic response (AR) to aeroallergens [2-4] that can lead to a reduction in patients’ quality of life and be an important trigger of exacerbations [5]. Experimental allergen challenge studies have shown the AR to comprise two temporal events, of which some subjects experience both while others experience only one [6]. The early AR (EAR) starts about 20 min after exposur