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Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense (Osiris)

This study has been completed.
ACM Pivotal Global Central Laboratory
Brecon Pharmaceuticals Ltd
Information provided by (Responsible Party):
ALK-Abelló A/S Identifier:
First received: August 26, 2011
Last updated: June 25, 2015
Last verified: June 2015
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.

Condition Intervention Phase
Rhino-conjunctivitis Biological: Osiris Phleum pratense Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense

Resource links provided by NLM:

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Tolerability based on reporting of adverse events [ Time Frame: An average of 42 days per subject ]
    Recording of adverse events are performed during the entire trial period, from screening to final follow-up contact.

Secondary Outcome Measures:
  • Subject satisfaction [ Time Frame: Measured at "End of treatment/end of trial Visit" ]
    To compare the subjects' satisfaction of the different dosing schedules at end of the trial (after 30 days of treatment with trial medication).

Enrollment: 236
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Osiris Phleum pratense - Group A

Group A up-dosing schedule from 1IR (index of Reactivity) /day to 240 IR/day in 11 days and thereafter 300 IR/day in 19 days.

Day 1-6: 1,2,4,6,8,10 IR/day Day 7-11: 30, 60, 120, 180, 240 IR/day Day 12-30: 300 IR/day

Biological: Osiris Phleum pratense
Active Comparator: Osiris Phleum pratense - Group B

Group B Up-dosing schedule:

Day 1-5: 50 IR/day Day 6-10: 150 IR/day Day 11-30: 300 IR/day

Biological: Osiris Phleum pratense
Active Comparator: Osiris Phleum pratense - Group C

Group C up-dosing schedule:

Day 1-10: 50 IR/day Day 11-20: 150 IR/day Day 21-30: 300 IR/day

Biological: Osiris Phleum pratense


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01425788

Poradnia Alergologii i Chorob Pluc Uniwersyteckiego Szpitala Klinicznego Nr1 im. N. Barlickiego w Lodzi
Lodz, Poland, 90-153
Sponsors and Collaborators
ALK-Abelló A/S
ACM Pivotal Global Central Laboratory
Brecon Pharmaceuticals Ltd
Principal Investigator: Piotr Kuna, Uniwersytecki Szpital Kliniczny Nr1, Lodz, Poland
  More Information

Responsible Party: ALK-Abelló A/S Identifier: NCT01425788     History of Changes
Other Study ID Numbers: OS-G-01
Study First Received: August 26, 2011
Last Updated: June 25, 2015

Keywords provided by ALK-Abelló A/S:
Grass pollen induced allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases processed this record on August 23, 2017