Status:
COMPLETED
Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis
Lead Sponsor:
Circassia Limited
Collaborating Sponsors:
Adiga Life Sciences, Inc.
Conditions:
Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. Worldwide, at least 4...
Detailed Description
This study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of ToleroMune Grass in subjects with a documented hi...
Eligibility Criteria
Inclusion
- Male or female, aged 18-65 years
- Minimum 2 year history of rhinoconjunctivitis on exposure to grass
- Positive skin prick test to whole grass allergen
- LPSR to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
- Positive CPT to whole grass allergen with a score ≥4
Exclusion
- Subjects with a history of asthma
- Subjects with an FEV1 \<80% of predicted
- Subjects with a rye grass specific IgE \>100 kU/L
- Subjects with an acute phase skin response to whole grass allergen with a mean wheal diameter \> 50 mm
- Subjects who score \>1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the CPT
- Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquillisers or psychoactive drugs
- History of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01166061
Start Date
July 1 2010
End Date
April 1 2011
Last Update
May 20 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre de Recherche Appliqué en Allergie de Québec
Québec, Quebec, Canada, G1V 4M6