A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ALK-Abelló A/S

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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