Status:
COMPLETED
ToleroMune Grass Follow on Study
Lead Sponsor:
Circassia Limited
Collaborating Sponsors:
Adiga Life Sciences, Inc.
Conditions:
Rhinoconjunctivitis
Grass Allergy
Eligibility:
All Genders
18-65 years
Brief Summary
Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-...
Detailed Description
This is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled, parallel group clinical study (TG002) which evaluated the efficacy, safety and tolerability of three doses of...
Eligibility Criteria
Inclusion
- Previously randomised into study TG002, and completed all treatment visits and PTC during calendar year 2012
Exclusion
- "Partly controlled" and "uncontrolled" asthama
- History of anaphylaxis to grass allergen
- FEV1 \<80% of predicted
- Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactuve drugs
- Symptoms of a clinically relevant illness
- Subjects who cannot tolerate allergen challenge in the EEU
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02292875
Start Date
April 1 2014
End Date
September 1 2014
Last Update
November 17 2014
Active Locations (2)
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1
Kanata, Ontario, Canada
2
Kingston, Ontario, Canada