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

NCT01728285 | Completed Phase 3

• 2 other identifiers: GT-17 ITALY2006-004820-35
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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

Conditions

Allergic Rhinitis; Grass Allergy

Keywords

specific allergen immunotherapy; sublingual immunotherapy; allergen tablets; compliance; electronic compliance device

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Electronic compliance device

ACTIVE COMPARATOR

Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®)

Device: 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®)

Interventions

Electronic compliance device (Memozax®) DEVICE

An electronic compliance device is distributed to patients allocated to the active arm

Electronic compliance device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, 27100, Italy

Location

Related 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;2012:673502. doi: 10.1155/2012/673502. Epub 2011 Nov 9.

  PMID: 22131999 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic; Patient Compliance

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 19, 2012
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

IT (1)