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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01425788
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : June 26, 2015
ACM Pivotal Global Central Laboratory
Brecon Pharmaceuticals Ltd
Information provided by (Responsible Party):
ALK-Abelló A/S

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.

Condition or disease Intervention/treatment Phase
Rhino-conjunctivitis Biological: Osiris Phleum pratense Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: ALK-Abelló A/S Identifier: NCT01425788     History of Changes
Other Study ID Numbers: OS-G-01
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases