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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004820-35 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic compliance device | Active Comparator | Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®) |
|
| No electronic compliance device | No Intervention | Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) without any electronic compliance device (Memozax®) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic compliance device (Memozax®) | Device | An electronic compliance device is distributed to patients allocated to the active arm |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo | Pavia | PV | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22131999 | Result | Alesina R, Milani M, Pecora S. A multicenter, randomized, parallel-group trial assessing compliance, tolerability, safety, and efficacy to treatment with grass allergy tablets in 261 patients with grass pollen rhinoconjunctivitis. J Allergy (Cairo). 2012;2012:673502. doi: 10.1155/2012/673502. Epub 2011 Nov 9. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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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 |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |