Comparison of Different Up-dosing Schedules With Osiris

August 26, 2011 updated by: ALK-Abelló A/S
The purpose of this study is to compare different up-dosing schedules with Osiris.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • uncontrolled and severe asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluate the tolerability of different up-dosing schedules
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
patient's satisfaction
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Study Registration Dates

First Submitted

November 11, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (ESTIMATE)

November 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2011

Last Update Submitted That Met QC Criteria

August 26, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OS-I-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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