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

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.

Study Overview

• Status: Completed
• Conditions: Rhino-conjunctivitis
• Intervention / Treatment: Biological: Osiris Phleum pratense

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 90-153
    • Poradnia Alergologii i Chorob Pluc Uniwersyteckiego Szpitala Klinicznego Nr1 im. N. Barlickiego w Lodzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction	To compare the subjects' satisfaction of the different dosing schedules at end of the trial (after 30 days of treatment with trial medication).	Measured at "End of treatment/end of trial Visit"

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Collaborators: Ergomed; ACM Pivotal Global Central Laboratory; Brecon Pharmaceuticals Ltd
• Investigators: Principal Investigator: Piotr Kuna, Prof.med, Uniwersytecki Szpital Kliniczny Nr1, Lodz, Poland

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (ESTIMATE): August 30, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 26, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Grass pollen induced allergic rhinoconjunctivitis
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: OS-G-01