Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis

Allergic Rhinitis Clinical Trial

— GT-17  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728285
• Other study ID #: GT-17 ITALY
• Secondary ID: 2006-004820-35
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2012
• Last updated: November 14, 2012
• Start date: March 2007
• Est. completion date: October 2009

Study information

• Verified date: November 2012
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ß2 agonists)

• Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Grass Allergy

Intervention

Device:
• Electronic compliance device (Memozax®)
An electronic compliance device is distributed to patients allocated to the active arm

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Impact of GRAZAX® treatment on allergy symptoms as compared to previous season	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	No
Secondary	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	No
Secondary	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	Yes