Clinical trial NCT01728285: Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis
Official title: A Multicentric Open Randomised, Cross-over Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Grass Allergy
Keywords: specific allergen immunotherapy
sublingual immunotherapy
allergen tablets
compliance
electronic compliance device
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2012-11-19
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: up to 1 year per patient
Secondary outcomes:
measure: Impact of GRAZAX® treatment on QoL as compared to previous season
timeFrame: up to 1 year per patient
measure: Impact of GRAZAX® treatment on allergy symptoms as compared to previous season
timeFrame: up to 1 year per patient
measure: Impact of GRAZAX® on treatment acceptance as compared to previous season
timeFrame: up to 1 year per patient
measure: Recording of all adverse events and serious adverse events
timeFrame: up to 1 year per patient
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: PV
Study officials:
References:
citation: 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.