Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis
- Conditions
- Allergic RhinitisGrass Allergy
- Interventions
- Device: Electronic compliance device (Memozax®)
- Registration Number
- NCT01728285
- Lead Sponsor
- ALK-Abelló A/S
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electronic compliance device Electronic compliance device (Memozax®) Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, PV, Italy