Status:
TERMINATED
Evaluation of the Utility of an EEC for Assessing Efficacy of SIT in Pivotal Clinical Trials
Lead Sponsor:
Allergopharma GmbH & Co. KG
Collaborating Sponsors:
Inflamax Research Incorporated
Conditions:
Allergic Rhinoconjunctivitis
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study will explore how allergy symptoms experienced during the grass pollen season compare to symptoms experienced in the Environmental Exposure Chamber (EEC). There are 2 treatments in this stud...
Detailed Description
This is a Phase II trial, with a one year observational/baseline phase followed by a one year double-blind placebo-controlled, randomized, treatment phase. Approx. 137 grass pollen-allergic subjects a...
Eligibility Criteria
Inclusion
- IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without allergic asthma
- positive skin prick test
- specific IgE ≥ 0.70 kU/L to mixture of grass pollen allergens
- symptom score of at least 4 per day during the week following the peak-pollen count in the baseline season
Exclusion
- undergone previous specific immunotherapy with grass pollen allergens in any formulation less than 5 years prior to the screening date
- currently undergoing any sort of immunotherapy, or has ever undergone specific immunotherapy with unknown allergen
- allergens which are expected to interfere with the grass pollen season
- uncontrolled or partly controlled asthma
- patients with contraindications for SIT
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT02297490
Start Date
January 1 2014
End Date
December 1 2014
Last Update
January 17 2018
Active Locations (1)
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1
Inflamax Research INC
Mississauga, Ontario, Canada, L4W 1A4