NCT01240954

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

First QC Date

November 11, 2010

Last Update Submit

August 26, 2011

Conditions

Allergic Rhinitis

Keywords

RhinitisAllergicImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • evaluate the tolerability of different up-dosing schedules

    30 days

Secondary Outcomes (1)

  • patient's satisfaction

    30 days

Study Arms (3)

OSIRIS

ACTIVE COMPARATOR
Drug: OSIRIS

OSIRIS other concentration 1

EXPERIMENTAL
Drug: OSIRIS other concentration 1

OSIRIS other concentration 2

EXPERIMENTAL
Drug: OSIRIS other concentration 2

Interventions

OSIRISDRUG

OSIRIS current practice

OSIRIS
OSIRIS other concentration 1DRUG

OSIRIS new concentration 1

OSIRIS other concentration 1
OSIRIS other concentration 2DRUG

OSIRIS new concentration 2

OSIRIS other concentration 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • uncontrolled and severe asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Krakow, Poland

Location

MeSH Terms

Conditions

Rhinitis, AllergicRhinitis

Interventions

Osi21 protein, Drosophila

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfections

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2010

First Posted

November 15, 2010

Study Start

December 1, 2010

Last Updated

August 29, 2011

Record last verified: 2011-08

Locations

PL(1)