Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Gr… (NCT01734265) | Clinical Trial Compass
CompletedPhase 2
Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml).
Spain63 participantsStarted 2012-11
Plain-language summary
The primary objective of this study is to evaluate the safety and tolerance of a rush build up administration of Depigoid forte pollen and the first maintenance dose administered 4 weeks later.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has dated and signed the informed consent.
* Men and women between 18 and 60 years of age (both inclusive).
* Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year, with or without allergic seasonal asthma caused by a clinically relevant sensitization to pollens (grasses AND P. judaica or O. europaea). Asthmatic patients can be included in the trial only if seasonal asthma is controlled with a medium daily dose minor or equal to 800 μg/day of budesonide or an equivalent or minor or equal to 400 μg/day of budesonide or an equivalent plus a long-acting- β2 agonist.
* Asthmatic patients must be stable within 3 months prior to Visit 1 and on an stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study. FEV1 must be ≥ 80% of predicted value.
* The IgE-mediated sensitization must be demonstrated by the following:
medical history AND IgE specific CAP RAST ≥ 2 to the suspected relevant pollens (grass pollen AND Olea and/or Parietaria) AND a positive skin prick test to grass and Olea and/or Parietaria.
Exclusion Criteria:
* Any contraindication for treatment with allergen specific immunotherapy.
* Forced expiratory volume in 1 s (FEV1) or peak expiratory flow (PEF) value \<80% of the predicted normal value.
* Clinically relevant allergy symptoms due to sensitization to perennial allergens (mites, molds, epithelia) or other seasonal pollen which might interfere with the …
What they're measuring
1
immediate or delayed systemic reaction of grade 2 or higher during the treatment period