CompletedPhase 3

A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma

Belarus, Russia112 participantsStarted 2015-10

Plain-language summary

To demonstrate superiority of ALK HDM tablets versus placebo in immune response, measured as change of D.farinae specific immunoglobulin G4 (IgG4) from baseline to end of treatment with ALK HDM tablets given once daily over 60 days.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male
✓. Female, infertile
✓. Female, with a negative pregnancy test and willingness to practice appropriate contraceptive methods until treatment with study drug has been discontinued.

What they're measuring

D. Farinae Specific IgG4 Change From Baseline to End of Treatment

Timeframe: 60 days from baseline

Trial details

NCT IDNCT02596321

SponsorAbbott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2017-07-21

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