CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Oral mucosal immunoprophylaxis (OMIP) +1 morebiological
Likely dose
Oral mucosal immunoprophylaxis (OMIP) 0.2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00346398
NCT00346398Phase 2Completed

A Phase II Multicenter, Controlled, Double-Blind Study Using Immunoprophylaxis in the Primary Prevention of Allergic Disease (ITN025AD)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 29, 2006·Updated May 1, 2017

In Brief

A Phase 2 clinical trial evaluating Oral mucosal immunoprophylaxis (OMIP) and Placebo for Asthma and Allergic Sensitization. Completed, enrolled 51 participants across 3 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether early childhood exposure to common allergens (substances that can trigger allergies and asthma) can prevent the development of asthma in children at high risk for developing the disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, United States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 29, 2006
Enrollment StartMay 1, 2006
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 20.0 years ago

Interventions

Oral mucosal immunoprophylaxis (OMIP)biological

OMIP consists of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL.

Placebobiological

The placebo consists of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL.