CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 76 enrolled
Drug / intervention
Ismigen +1 moredrug
Likely dose
Ismigen 7 mgfrom 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/NCT04270552
NCT04270552Phase 3Completed
CompareCT.gov

The Effect Of Polivalent Mechanical Bacterial Lysate On The Clinical Course Of Grass Pollen-Induced Allergic Rhinitis In Children

Medical University of Lublin·interventional·Posted Feb 17, 2020·Updated Mar 17, 2021

In Brief

A Phase 3 clinical trial evaluating Ismigen and Placebo for Allergic Rhinitis. Completed, enrolled 76 participants across 1 site.

Detailed Summary

This study evaluate the efficacy of Polyvalent Mechanical Bacterial Lysate (PMBL - Ismigen) to improve the clinical course of grass pollen-induced allergic rhinitis (using: TNSS, TOSS, VAS, PNIF) in children aged 5 to 17. Half of the 70 participants will receive PMBL while the other half will receive placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis
CountriesPoland
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartApr 22, 2018
Primary CompletionJul 20, 2018
Study CompletionAug 12, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.4 years ago

Interventions

Ismigendrug

Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24) - sublingual use 1 tablet per day over 10 days for 3 successive months.

Placebodrug

Matched tablets without any active substance.