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

Grass Pollen Allergy Clinical Trial

Official title:

A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment Initiated in the Grass Pollen Season in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773240
• Other study ID #: GT-18
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2008
• Last updated: August 27, 2011
• Start date: April 2008
• Est. completion date: February 2009

Study information

• Verified date: August 2011
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: February 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Grass Pollen Allergy
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Grazax
1 tablet, 75,000 SQ-T, daily during the trial period
• placebo
1 placebo tablet, matching the active treatment, daily during the trial period

Locations

Country	Name	City	State
Denmark	ALK-Abello A/S, Bøge alle 6-8	Hørsholm

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics - Immunological assessments		Pre- and post treatment	No