Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctiviti… (NCT01634958) | Clinical Trial Compass
CompletedPhase 2
Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Germany308 participantsStarted 2012-10
Plain-language summary
Specific immunotherapy for IgE mediated sensitization to grass pollen
4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the optimum dose.
Who can participate
Age range18 Years – 70 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:
* appropriately signed and dated ICON prior to study specific action
* IgE-mediated Sensitization against grass pollen
* Perception of disease activity of at least 30 mm on a 100 mm VAS
* FEV1 or a PEFR value \> 80% of predicted normal value
* Allergic rhinitis and/or rhinoconjunctivitis symptoms (at least 2 years) with or without intermittent asthma symptoms verified by:
* suggestive medical history AND
* specific IgE against grass pollen with CAP-RAST ≥ 2 AND
* a positive SPT (wheal diameter ≥ 3 mm) AND
* a positive CPT for grass pollen
* Patients with co-allergies are allowed to enter the study:
* being asymptomatic against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens
* with CAP-RAST co-allergen \< grass (detailed specifications given for Birch, HDM, animal dander, other country specific allergens)
* All other co-allergens: difference in CAP RAST co-allergen to grass of ≥ 2 and an SPT wheal diameter co-allergen \< grass
* Females of non-childbearing potential must be postmenopausal for at least
1 year or surgically sterilized
* Females of childbearing potential must be non-lactating, non-pregnant and must correctly use an effective method of contraception during the study.
Exclusion Criteria:
* Acute or chronic infectious conjunctivitis
* History of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial a…
What they're measuring
1
Conjunctival Provocation Test (CPT)
Timeframe: At screening and after approx. 22 weeks (EoS)