ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Different Up-dosing Schedules With Osiris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01240954
Recruitment Status : Terminated (CA approval not obtained)
First Posted : November 15, 2010
Last Update Posted : August 29, 2011
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: OSIRIS Drug: OSIRIS other concentration 1 Drug: OSIRIS other concentration 2 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. evaluate the tolerability of different up-dosing schedules [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. patient's satisfaction [ Time Frame: 30 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240954


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

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01240954     History of Changes
Other Study ID Numbers: OS-I-01
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: August 29, 2011
Last Verified: August 2011

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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases