NCT01059266

PURETHAL Grasses Rush Study

A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks). The primary parameter will be the proportion of patients who experience systemic reactions \> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached. It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.

Conditions

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	PURETHAL Grasses, 20.000 AUM/ml	subcutaneous injections of increasing doses according to the described regimen

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-01-29
• Last updated: 2012-02-10

Locations

11 sites across 1 country: Germany