Comparison of Different Up-dosing Schedules With Osiris Phleum Pratense

This study has been completed.
Sponsor:
Collaborators:
Ergomed
ACM Pivotal Global Central Laboratory
Brecon Pharmaceuticals Ltd
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01425788
First received: August 26, 2011
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Secondary Outcome Measures:
  • Subject satisfaction [ Designated as safety issue: No ]
    To compare the subjects' satisfaction of the different dosing schedules


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425788

Locations
Poland
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
Ergomed
ACM Pivotal Global Central Laboratory
Brecon Pharmaceuticals Ltd
Investigators
Principal Investigator: Piotr Kuna, Prof.med Uniwersytecki Szpital Kliniczny Nr1, Lodz, Poland
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01425788     History of Changes
Other Study ID Numbers: OS-G-01
Study First Received: August 26, 2011
Last Updated: March 29, 2012
Health Authority: Poland: Ministry of Health

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

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014