Depigoid Birch 5000 Longterm Study in Adults and Adolescents (NCT01694836) | Clinical Trial Compass
CompletedPhase 3
Depigoid Birch 5000 Longterm Study in Adults and Adolescents
Germany634 participantsStarted 2012-09-17
Plain-language summary
Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula alba (Birch) - versus placebo.
Who can participate
Age range12 Years – 70 Years
SexALL
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Inclusion Criteria:
* Availability of an appropriately signed and dated informed consent before any study specific examination,
* Clinical history of at least 2 years of seasonal allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma due to birch pollen allergy that has required repeated use of symptomatic treatment,
* Patients must have a minimum level of perception of symptoms from previous seasons defined as at least a moderate symptom level (i.e. a score of 2 on the 4-point-Likert scale) in at least 2 symptom categories prior to randomization,
* Lung function ≥ 80% of the predicted normal value,
* IgE-mediated sensitization has to be verified by:
* suggestive medical history, and
* specific IgE reactivity to birch pollen (CAP-RAST ≥ 2), and
* a positive SPT to birch pollen at screening or within 1 months prior to the screening visit. An SPT is considered positive if it results in a wheal diameter of at least 3.0 mm
* Internet access so that patients can complete the eDiary daily via internet during all 5 pollen seasons covered by the study protocol.
Exclusion Criteria:
* History of significant clinical manifestations of allergy as a result of sensitization against co-allergies, particularly-but not limited to-grass or weed pollen and perennial allergens (e.g. house dust mites, cat or dog).
* History of anaphylactic reaction.
* Moderate or severe persistent asthma (GINA 3 or 4).
* Mild persistent asthma (GINA 2), according to the Global …
What they're measuring
1
Proof of efficacy (superiority vs. placebo) by means of the combined Symptom and Medication Score (SMS).