Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis

ALK-Abelló A/S261 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

261

Conditions

Allergic Rhinitis Grass Allergy

Interventions

Electronic compliance device (Memozax®)DEVICE

An electronic compliance device is distributed to patients allocated to the active arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, Italy

Outcomes

Primary Outcomes

To evaluate if compliance with grass Allergy Immunotherapy Tablet can be increased by providing an electronic compliance device (CED) (Memozax; a tablet-container with a programmable daily acoustic alarm)

To evaluate if compliance of once daily dosing with Grazax in adult subjects with grass pollen induced allergic rhinoconjunctivitis can be increased by providing patients with an electronic compliance device. Compliance in the two groups (with Memozax and without Memozax) was evaluated by tablet counts