A Multicentric Open Randomised, Cross-over Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 261
- Locations
- 2
- Primary Endpoint
- 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)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
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)
Time Frame: 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 Outcomes
- Impact of GRAZAX® treatment on QoL as compared to previous season(up to 1 year per patient)
- Impact of GRAZAX® treatment on allergy symptoms as compared to previous season(up to 1 year per patient)
- Impact of GRAZAX® on treatment acceptance as compared to previous season(up to 1 year per patient)
- Recording of all adverse events and serious adverse events(up to 1 year per patient)