Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis (GT-17)

November 14, 2012 updated by: ALK-Abelló A/S

A Multicentric Open Randomised, Cross-over Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Electronic compliance device
Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®)
Device: Electronic compliance device (Memozax®)
An electronic compliance device is distributed to patients allocated to the active arm
No Intervention: No electronic compliance device
Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) without any electronic compliance device (Memozax®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 year per patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of GRAZAX® treatment on QoL as compared to previous season
Time Frame: up to 1 year per patient
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
Impact of GRAZAX® treatment on allergy symptoms as compared to previous season
Time Frame: up to 1 year per patient
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
Impact of GRAZAX® on treatment acceptance as compared to previous season
Time Frame: up to 1 year per patient
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
Recording of all adverse events and serious adverse events
Time Frame: up to 1 year per patient
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 19, 2012

Study Record Updates

Last Update Posted (Estimate)

November 19, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-17 ITALY
  • 2006-004820-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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