Status:
COMPLETED
Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense
Lead Sponsor:
ALK-Abelló A/S
Collaborating Sponsors:
Ergomed
ACM Pivotal Global Central Laboratory
Conditions:
Rhino-conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
- Severe asthma exacerbation(s) within the last 12 months
- A clinically relevant chronic disease (\>/= 3 months) (e.g fibrosis, malignancy, type 1 diabetes mellitus, malabsorption or malnutrition, renal or hepatic insufficiency)
- Malignancy or systemic disease affecting the immune system (e.g. autoimmune disease, immune complex disease or immune deficiency disease)
- Inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis or dental extraction at randomisation
- Medical history of recurrent urticaria or atopic dermatitis during the last 2 years
- Currently receiving treatment preventing the initiation of SIT (e.g. tricyclic antidepressants, mono amine oxidase inhibitors (MAOIs) and catechol-O-methyl transferase inhibitors (COMT inhibitors))
- History of allergy, hypersensitivity, or intolerance to the excipients of the investigational medicinal product
- Being immediate family of the investigator or trial staff, defined as the investigator's / staff's spouse, parent, grandparent, child or grandchild
- History of drug induced (incl. immunotherapy) facial angioedema (including experience of Quincke oedema) or a family (parents or siblings) history of hereditary angioedema
- Anticipated use of any prohibited medication within the specified time windows as defined in the protocol
- Previous treatment by immunotherapy with grass pollen for more than one month within the last 5 years
- Any clinically significant condition or situation, other than the condition being studied, that in the opinion of the investigator would interfere with the trial evaluations or optimal participation
- History of anaphylaxis with cardio respiratory symptoms (e.g. food allergy, drugs or an idiopathic reaction)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01425788
Start Date
August 1 2011
End Date
February 1 2012
Last Update
June 26 2015
Active Locations (1)
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1
Poradnia Alergologii i Chorob Pluc Uniwersyteckiego Szpitala Klinicznego Nr1 im. N. Barlickiego w Lodzi
Lodz, Poland, 90-153