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Comparison of Different Up-dosing Schedules With Osiris

This study has been terminated.
(CA approval not obtained)
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01240954
First received: November 11, 2010
Last updated: August 26, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Allergic Rhinitis
 Drug: OSIRIS
Drug: OSIRIS other concentration 1
Drug: OSIRIS other concentration 2
 Phase 2

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

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • evaluate the tolerability of different up-dosing schedules [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient's satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: December 2010
Arms Assigned Interventions
Active Comparator: OSIRIS Drug: OSIRIS
OSIRIS current practice
Experimental: OSIRIS other concentration 1 Drug: OSIRIS other concentration 1
OSIRIS new concentration 1
Experimental: OSIRIS other concentration 2 Drug: OSIRIS other concentration 2
OSIRIS new concentration 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • uncontrolled and severe asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240954

Locations
Poland
Kraków, Poland
Sponsors and Collaborators
ALK-Abelló A/S
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01240954     History of Changes
Other Study ID Numbers: OS-I-01
Study First Received: November 11, 2010
Last Updated: August 26, 2011
Health Authority: Poland: Ministry of Health

Keywords provided by ALK-Abelló A/S:
Rhinitis
Allergic
Immunotherapy

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013