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NCT01240954 Clinical Trial

Comparison of Different Up-dosing Schedules With Osiris

Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01240954
Other study ID # OS-I-01
Secondary ID
Status Terminated
Phase Phase 2
First received November 11, 2010
Last updated August 26, 2011
Start date December 2010

Study information
Verified date August 2011
Source ALK-Abelló A/S
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 210
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- history of grass pollen allergy

- Positive SPT to grass

- Positive IgE to grass

Exclusion Criteria:

- uncontrolled and severe asthma

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• OSIRIS
OSIRIS current practice
• OSIRIS other concentration 1
OSIRIS new concentration 1
• OSIRIS other concentration 2
OSIRIS new concentration 2

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary evaluate the tolerability of different up-dosing schedules 30 days No
Secondary patient's satisfaction 30 days No
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