Comparison of Different Up-dosing Schedules With Osiris

Phase 2

Terminated

• Conditions: Allergic Rhinitis
• Interventions: Drug: OSIRIS; Drug: OSIRIS other concentration 1; Drug: OSIRIS other concentration 2

• Registration Number: NCT01240954
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

The purpose of this study is to compare different up-dosing schedules with Osiris.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-11
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Study Start: 2010-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-26
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• history of grass pollen allergy
• Positive SPT to grass
• Positive IgE to grass

Exclusion Criteria

• uncontrolled and severe asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSIRIS	OSIRIS	-
OSIRIS other concentration 1	OSIRIS other concentration 1	-
OSIRIS other concentration 2	OSIRIS other concentration 2	-

Primary Outcome Measures

Name	Time	Method
evaluate the tolerability of different up-dosing schedules	30 days

Secondary Outcome Measures

Name	Time	Method
patient's satisfaction	30 days