Status:
COMPLETED
A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Grass Pollen Allergy
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis
Eligibility Criteria
Inclusion
- Positive skin prick test to Phleum pratense
- Positive IgE to Phleum pratense
- signed informed consent
- A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms
Exclusion
- No uncontrolled asthma in the past 12 months
- No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
- No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00773240
Start Date
April 1 2008
End Date
February 1 2009
Last Update
August 30 2011
Active Locations (1)
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1
ALK-Abello A/S, Bøge alle 6-8
Hørsholm, Denmark, DK-2970