At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 41 enrolled

Drug / intervention

Allergovit +1 moredrug

Likely dose

Allergovit 0.1 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/NCT01475188

NCT01475188Phase 4Completed

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Regulatory Lymphocytes (Treg) in the Modulation of Allergic Inflammation in Patients Treated With Specific Immunotherapy.

Ministry of Science and Higher Education, Poland·interventional·Posted Nov 21, 2011·Updated Nov 21, 2011

In Brief

A Phase 4 clinical trial evaluating Allergovit and placebo for Immunotherapy and Seasonal Allergic Rhinitis. Completed, enrolled 41 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether specific subcutaneous immunotherapy affects fractions of regulatory T lymphocytes and histamine H2 receptor expression and ZAP70 in regulatory T lymphocytes.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsImmunotherapy, Seasonal Allergic Rhinitis

CountriesPoland

Collaborators--

Timeline

Phase 4CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2007

Primary CompletionOct 2010

Study CompletionDec 2010

First PostedNov 2011

TodayJul 2026

First PostedNov 21, 2011

Enrollment StartMar 1, 2007

Primary CompletionOct 1, 2010

Study CompletionDec 1, 2010

TodayJul 2, 2026

Enrollment to primary: 3.6 yearsPosted 14.6 years ago

Interventions

Allergovitdrug

commercially available grass pollen allergoid (100%), concentration A (1000 TU/ml, therapeutic units/ml)concentration B (10000 TU/ml).Patients were given subcutaneous injections with initial dose of 0.1 ml (concentration A) was increased once a 7 (+7) days until the highest tolerated dose (0.6, concentration B) was reached and SIT was continued with injections once every 4 - 6 weeks up to two years.

placeboother

placebo administered with the same scheme and doses as specific subcutaneous immunotherapy