Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense (NCT01425788) | Clinical Trial Compass
CompletedPhase 2
Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense
Poland236 participantsStarted 2011-08
Plain-language summary
The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current practice.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent obtained before entering the trial
* Male or female \>/= 18 years at visit 1
* A clinically relevant history of grass pollen induced allergic rhinoconjunctivitis (moderate to severe) and having received symptomatic treatment during grass pollen season 2010 and 2011
* Positive skin prick test response (wheal diameter \>/= 3mm) to Phleum pratense
* Positive specific IgE against Phleum pratense (\>/= 0,70KUL / class 2)
* Female subjects of childbearing potential must have a negative pregnancy test and be willing to practice appropriate contraceptive methods until Visit 4
* Subjects willing and able to comply with trial protocol regimen
Exclusion Criteria:
* Subjects included in another protocol (treatment intervention and/or investigational medicine product) or having participated in another clinical trial within 30 days prior to visit 1
* A clinically relevant history of symptomatic seasonal allergic rhinoconjunctivitis caused by an allergen (e.g. hazel, alder, birch, ash) to which the subject will be exposed during the 30-day treatment period.
* A clinically relevant medical history of symptomatic perennial allergy to allergen(s) to which the subject is regularly exposed (e.g. cat, house dust mites).
* Known sensitization (history of positive SPT) to food allergens with oral allergy syndrome
* Uncontrolled asthma (in accordance with GINA guidelines) within the last 12 months
* FEV \< 60% of predicted within the last 12 months
*…