Safety Study of Depigoid Vaccine Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyss… (NCT01591343) | Clinical Trial Compass
TerminatedPhase 2
Safety Study of Depigoid Vaccine Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml), to Treat Allergic Rhinitis or Rhinoconjunctivitis With or Without Asthma
Stopped: Study halted by Sponsor
Spain8 participantsStarted 2012-06
Plain-language summary
Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma.
Primary variable: number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.
Who can participate
Age range18 Years – 55 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:
* Men and women between 18 and 55 years of age (both inclusive).
* Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year -- with or without symptoms of mild persistent or intermittent allergic asthma which is controlled with a dose less or equal to 400 µg/day budesonide or an equivalent -- caused by a clinically relevant sensitization to house dust mites (Dermatophagoides pteronyssinus or Dermatophagoides pteronyssinus and Dermatophagoides farinae).
* The IgE-mediated sensitization will be demonstrated by means of the following: medical history and IgE specific to house dust mites (D. pteronyssinus or D. pteronyssinus and D. farinae) CAP RAST ≥ 2 and positive skin prick test. A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter.
* Asthmatic patients must be stable and on a stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study.
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.
* Allergy symptoms due to sensitization to pollens or other perennial allergens (molds, epithelia).
* Subjects with typical symptoms to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelial cells cannot participate in this study. Patients sensitiz…