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Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis

NCT02245360 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2016-01-11

Study results available
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Summary

To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Phleum pratense grass pollen allergen extract

Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days

DRUG

placebo

placebo tablet given once daily over 60 days

Sponsors & Collaborators

Principal Investigators

  • Dmitri Kazei, MD PhD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Russia

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02245360 on ClinicalTrials.gov