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

Study Overview
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Brief Summary
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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

Official Title
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A Multicentric Open Randomised, Cross-over Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Conditions
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Allergic Rhinitis, Grass Allergy

Intervention / Treatment
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* Device: Electronic compliance device (Memozax®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electronic compliance device<br>Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®) | Device: Electronic compliance device (Memozax®)<br>* An electronic compliance device is distributed to patients allocated to the active arm<br>|
| No Intervention: No electronic compliance device<br>Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) without any electronic compliance device (Memozax®) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 1 year per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of GRAZAX® treatment on QoL as compared to previous season | To evaluate after one-year treatment with Grazax tablets the impact on quality of life in comparison with previous pollen seasons | up to 1 year per patient | 
| Impact of GRAZAX® treatment on allergy symptoms as compared to previous season | To evaluate after one-year treatment with Grazax tablets the impact on symptom score in comparison with previous pollen seasons | up to 1 year per patient | 
| Impact of GRAZAX® on treatment acceptance as compared to previous season | To evaluate after one-year treatment with Grazax tablets the impact on patient's acceptance in comparison with previous pollen seasons | up to 1 year per patient | 
| Recording of all adverse events and serious adverse events | The safety assessments included recording of all adverse events (AE) and serious adverse events (SAE) findings from physical examinations and from vital signs | up to 1 year per patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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specific allergen immunotherapy, sublingual immunotherapy, allergen tablets, compliance, electronic compliance device