Asthma and lower airway diseaseStandardized quality (SQ) house dust mite sublingual immunotherapy tablet (ALK) reduces inhaled corticosteroid use while maintaining asthma control: A randomized, double-blind, placebo-controlled trial
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Ethics
The trial is identified by EudraCT number 2006-001795-20 and ClinicalTrials.gov Identifier NCT00389363. The trial was designed, approved, consented to, and conducted according to the principles of ICH Good Clinical Practice.17
Intervention medication
The tablets (active and placebo) were manufactured and provided by the sponsor and were oral lyophilisates, either containing standardized extracts of Dermatophagoides pteronyssinus and Dermatophagoides farinae in a 1:1 ratio or a placebo that was similar in appearance,
Trial population
Subject disposition is summarized in Table I. The full analysis set (FAS) comprised 604 randomized subjects. Eighty-eight percent completed the trial, evenly distributed over treatment groups. The rate of AE discontinuations was numerically slightly higher for 3 SQ-HDM than for the other treatment groups.
Demographic and selected baseline characteristics are summarized in Fig 2. All parameters were generally similar between treatment groups, and baseline body characteristics were within the
Discussion
The trial was double-blinded, and no indications of generally compromised blinding were present during the trial. It has previously been discussed whether the occurrence of local side effects with SLIT-tablets could potentially compromise blinding.35 An analysis of data pooled from 4 clinical trials investigating the effect of an SQ grass SLIT-tablet in patients with allergic rhinoconjunctivitis has been conducted. The data were pooled to ensure sufficient power of the subgroup analyses, and
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Sponsored by ALK-Abelló, Hørsholm, Denmark, who assumes overall responsibility for the trial and has been involved in both trial design and conduct.
Disclosure of potential conflict of interest: H. Mosbech has received consultancy fees for help in preparation of protocol, has received support for travel to European congresses and international allergologic and pulmonologic congresses, is an advisory board member, and has received lecture fees for postgraduate educational activities on allergologic topics from ALK-Abelló. F. de Blay has received research support, consultancy fees, travel support, and participation fees from ALK-Abelló; is a board member for and has received consultancy fees from Novartis, Boehringer, Stallergenes, and Meda Pharma; has received research support from AstraZeneca; and has received lecture fees from Novartis, Stallergenes, Meda Pharma, GlaxoSmithKline, and MSD. L. Prieto Andres is a board member for GlaxoSmithKline, Novartis, and Stallergenes and has received lecture fees from GlaxoSmithKline and Novartis. C. Ljørring is employed by and has stock/stock options in ALK-Abelló. G. W. Canonica has received research support from ALK-Abelló, Almirall, Allergy Therapeutics, Allergopharma, Anallergo, HAL, Lofarma, and Stallergenes. The rest of the authors declare that they have no relevant conflicts of interest.