Allergic Rhinitis, Grass Allergy
Conditions
Keywords
specific allergen immunotherapy, sublingual immunotherapy, allergen tablets, compliance, electronic compliance device
Brief summary
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
Interventions
DEVICEElectronic compliance device (Memozax®)
An electronic compliance device is distributed to patients allocated to the active arm
Sponsors
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | up to 1 year per patient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of GRAZAX® treatment on QoL as compared to previous season | up to 1 year per patient | To evaluate after one-year treatment with Grazax tablets the impact on quality of life in comparison with previous pollen seasons |
| Impact of GRAZAX® treatment on allergy symptoms as compared to previous season | up to 1 year per patient | To evaluate after one-year treatment with Grazax tablets the impact on symptom score in comparison with previous pollen seasons |
| Impact of GRAZAX® on treatment acceptance as compared to previous season | up to 1 year per patient | To evaluate after one-year treatment with Grazax tablets the impact on patient's acceptance in comparison with previous pollen seasons |
| Recording of all adverse events and serious adverse events | up to 1 year per patient | The safety assessments included recording of all adverse events (AE) and serious adverse events (SAE) findings from physical examinations and from vital signs |
Countries
Italy
Outcome results
None listed