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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2014