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

Phase 3

Completed

• Conditions: Grass Pollen Allergy
• Interventions: Drug: Grazax; Drug: placebo

• Registration Number: NCT00773240
• Lead Sponsor: ALK-Abelló A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-10
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Study Completion: 2009-02
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-27
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Grazax	Grazax
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics - Immunological assessments	Pre- and post treatment

Trial Locations

Locations (1)

ALK-Abello A/S, Bøge alle 6-8; 🇩🇰 Hørsholm, Denmark