CompletedNot Applicable

Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

Denmark, France, Latvia196 participantsStarted 2014-02

Plain-language summary

Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Any subject having been randomized in the AN004T trial and had received at least one injection
✓. Any subject having been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments

Exclusion criteria

✕. Any subject having received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since AN004T and before Visit 1
✕. Any subject intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days
✕. Any subject unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
✕. Any subject not covered by medical insurance
✕. Any subject having received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period
✕. Any subject having received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion
✕. Any subject having used any investigational or non-registered drug, vaccine, or medical device within 4 weeks prior to inclusion, or planned to use such treatments during the trial period

What they're measuring

Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season

Timeframe: from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3

Trial details

NCT IDNCT02143583

SponsorAnergis

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-07

Results submitted2015-03-23

View on ClinicalTrials.gov More Birch Pollen Allergy trials