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

NCT ID: NCT01728285

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-10-31

Brief Summary

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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

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Conditions

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Allergic Rhinitis Grass Allergy

Keywords

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specific allergen immunotherapy sublingual immunotherapy allergen tablets compliance electronic compliance device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electronic compliance device

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

Group Type ACTIVE_COMPARATOR

Electronic compliance device (Memozax®)

Intervention Type DEVICE

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

No electronic compliance device

Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) without any electronic compliance device (Memozax®)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electronic compliance device (Memozax®)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS Policlinico San Matteo

Pavia, PV, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 22131999 (View on PubMed)

Other Identifiers

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2006-004820-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GT-17 ITALY

Identifier Type: -

Identifier Source: org_study_id