Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis (GT-17)

ALK-Abelló

Status and phase

Completed

Phase 3

Conditions

Allergic Rhinitis

Grass Allergy

Treatments

Device: Electronic compliance device (Memozax®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01728285

2006-004820-35 (EudraCT Number)

GT-17 ITALY

Details and patient eligibility

About

Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment of allergic rhinitis, which has to be taken daily by patients. This study was aimed to establish if a device with the characteristics of a mechanical dispenser (Memozax®) could improve adherence to treatment in subjects with hay fever due to allergy to grass

Enrollment

261 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A clinical history of grass pollen-induced allergic rhinoconjunctivitis (with or without asthma) having received treatment during the previous grass pollen season.
Positive skin prick test (SPT) response (wheal diameter ≥3mm) to Phleum pratense
Positive specific IgE against Phleum pratense (IgE titer > class 2)

Exclusion criteria

Clinical history of chronic sinusitis during the last 2 years or of symptomatic perennial or seasonal allergic rhinitis and/or asthma having received regular medication, due to another allergen during - or potentially overlapping - the grass pollen season.
Clinical history of severe asthma (GINA Step 4 and children with Forced Expiratory Volume in 1 second (FEV1) < 80% of expected value after treatment with inhaled corticosteroids and short-acting β2 agonists)
Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years