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

Abbott

Status and phase

Completed

Phase 3

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: Phleum pratense grass pollen allergen extract

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02245360

GRAS3001

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 microgram budesonide or equivalent
Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))

Exclusion criteria

Reduced lung function (defined as FEV1 < 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
Clinical history of uncontrolled asthma within 3 months prior to the screening visit