METHODS: 554 patients with moderate to severe grass pollen-induced rhinoconjunctivitis who participated in double-blind placebo-controlled trial were randomized 1:2 to receive weekly administrations of placebo or increasing doses of LPP to reach a cumulative dose of 170µg within 3weeks prior to the pollen season. Quality of life was assessed before, during and after the season using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)) and the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ).
RESULTS: Global RQLQ and NRQLQ scores were similar in both groups before the pollen season [mean total,95%CI;0.6518(0.5461;0.7576) and 0.4569(0.3720;0.5418)] in the LPP and [0.6968 (0.5547;0.8389) and 0.4919(0.3706;0.6131)] in the placebo. Moreover, global RQLQ and NRQLQ scores significantly lower in the LPP group during the pollen season [1.1665(1.0517;1.2813) and 0.7886(0.6913;0.8860]) for LPP compared to[1.4074(1.2402;1.5745) and 0.9441(0.8068;1.0814)] in the placebo-treated group(p<0.01). Improvement of QoL was observed in all domains in LPP-treated patients compared to placebo. The improved quality of life in LPP-treated patients compared to placebo was in line with the higher number of well days(+23%,p=0.044) reported during the peak pollen period.
CONCLUSIONS: A 3-week treatment with increasing doses of LPP confers significant clinical benefit in hay fever patients under natural exposure to grass pollen as measured by patient-reported quality of life assessments.