Clinical trial NCT01425788: Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense
Official title: Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhino-conjunctivitis
Keywords: Grass pollen induced allergic rhinoconjunctivitis
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Ergomed
name: ACM Pivotal Global Central Laboratory
name: Brecon Pharmaceuticals Ltd
First posted: 2011-08-30
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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
* 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)

Primary outcomes:
measure: Tolerability based on reporting of adverse events
timeFrame: An average of 42 days per subject
Secondary outcomes:
measure: Subject satisfaction
timeFrame: Measured at "End of treatment/end of trial Visit"
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Poradnia Alergologii i Chorob Pluc Uniwersyteckiego Szpitala Klinicznego Nr1 im. N. Barlickiego w Lodzi
Study officials:
affiliation: Uniwersytecki Szpital Kliniczny Nr1, Lodz, Poland
name: Piotr Kuna, Prof.med
role: PRINCIPAL_INVESTIGATOR
References: