Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctiv… (NCT01144429) | Clinical Trial Compass
CompletedPhase 2
Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Germany344 participantsStarted 2010-06
Plain-language summary
Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose.
4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therapy 20 weeks. Primary criterion is the Conjunctival Provocation Test (CPT), i.e. comparison between treatment arms of increased amount of quantities of allergen to provoke a positive CPT at the end of treatment.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Patients have provided an appropriately signed and dated informed consent prior to any study specific examination,
✓. Patients must be ≥ 18 and ≤ 70 years of age at Visit 1,
✓. Patients must have a perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS),
✓. Patients must have an FEV1 or PEF value \> 80% of the predicted normal value (for PEF: highest result of 3 measurements),
✓. Patients must complain about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years with or without intermittent asthma symptoms, caused by clinical sensitization against birch pollen,
✓. IgE-mediated sensitization has to be verified by:
✓. Patients do not suffer from typical symptoms against co-allergens,
✓. Specific CAP-RAST against co-allergens \< CAP-RAST against birch pollen (the difference has to be ≥ 2), patients with co-allergens against animal dander can be randomized even if the CAP RAST difference is \< 2, but must not be exposed to the specific allergen,
Exclusion criteria
✕. Acute and chronic conjunctivitis,
✕. Infectious conjunctivitis,
✕. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens (e.g. house dust mites),
What they're measuring
1
Conjunctival Provocation Test
Timeframe: At screening and after approx 22 weeks (EoS)