Rhinitis, sinusitis, and upper airway diseaseEfficacy and safety of sublingual tablets of house dust mite allergen extracts: Results of a dose-ranging study in an environmental exposure chamber
Section snippets
Trial design
This randomized, double-blind, placebo-controlled study (Fig 1) was conducted at 8 centers in Canada (ClinicalTrials.gov no. NCT01527188). All allergen challenges in the EEC were performed at Cetero Research/PRACS Institute (Mississauga, Ontario). The study was approved by the appropriate institutional review boards and Health Canada and was performed according to Good Clinical Practices guidelines of the International Conference on Harmonization. Written informed consent was obtained from all
Subject disposition
A total of 355 subjects were randomized and constituted the Full Analysis Set: 500IR (n = 93), 300IR (n = 86), 100IR (n = 89), and placebo (n = 87); 288 (81%) completed the study (Fig 2).
Demographic and baseline disease characteristics were similar across the groups (Table I). The mean age was 32 years, the mean duration of allergic rhinitis was 17 years, about 76% were polysensitized, and about 13% had asthma.
Efficacy analysis
On the primary end point, the ChBLAUCRTSS 0-4h after 6 treatment months, a
Discussion
This placebo-controlled dose-ranging study, conducted using allergen challenges in an EEC, was designed to evaluate the effect of treatment with 500IR, 300IR, and 100IR sublingual tablets of HDM allergen extracts in adults with HDM-induced allergic rhinitis. After 6 months of treatment, a dose-dependent effect was observed on rhinitis symptoms as evidenced by changes from baseline in the AUC of the RTSS and the ARTSS. This effect was also reflected in the change from baseline in VAS scores,
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Cited by (0)
This study was funded by Stallergenes S.A., France.
Disclosure of potential conflict of interest: M. Roux, A. Montagut, K. Abiteboul, A. Viatte, and R. K. Zeldin are employees of Stallergenes S.A. P. Devillier has received consulting fees from Stallergenes S.A. and has received honoraria for board membership, consultancy, lectures, and/or manuscript preparation from ALK, Almirall, Astra-Zeneca, Boehringer-Ingelheim, Chiesi, CLL Pharma, GlaxoSmithKline, Meda Pharma, Mundipharma, Novartis, Sandoz, Stallergenes S.A., and Teva. W. H. Yang has received research grants from Stallergenes S.A.