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

Last updated: December 9, 2015
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Common Cold

Nasal Obstruction

Allergy

Treatment

N/A

Clinical Study ID

NCT02245360
GRAS3001
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.

  • Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.

  • Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.

  • If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgrambudesonide or equivalent

  • Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (definedas ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))

Exclusion

Exclusion Criteria:

  • Reduced lung function (defined as FEV1 < 70% (FEV1=Forced Expiratory Volume in 1second) of predicted value after adequate pharmacologic treatment) measured at Visit 1and Visit 2

  • Clinical history of uncontrolled asthma within 3 months prior to the screening visit

Study Design

Total Participants: 107
Study Start date:
October 01, 2014
Estimated Completion Date:
March 31, 2015

Connect with a study center

  • Research facility ID ORG-001005

    Moscow, 115478
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001006

    Moscow, 123182
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001009

    Moscow, 119333
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001014

    Moscow, 142190
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001016

    Moscow, 119991
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001018

    Moscow, 115446
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001085

    Moscow, 123182
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001086

    Moscow, 105077
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001015

    Samara, 443099
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001021

    Saratov, 410028
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001017

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001007

    St. Petersburg, 193231
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001008

    St. Petersburg, 198216
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001019

    St. Petersburg, 195030
    Russian Federation

    Site Not Available

  • Research facility ID ORG-001020

    Ufa, 450000
    Russian Federation

    Site Not Available

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