Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis (GT-17)
Primary Purpose
Allergic Rhinitis, Grass Allergy
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Electronic compliance device (Memozax®)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring specific allergen immunotherapy, sublingual immunotherapy, allergen tablets, compliance, electronic compliance device
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
Sites / Locations
- Fondazione IRCCS Policlinico San Matteo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Electronic compliance device
No electronic compliance device
Arm Description
Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®)
Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) without any electronic compliance device (Memozax®)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01728285
Brief Title
Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Grass Allergy
Keywords
specific allergen immunotherapy, sublingual immunotherapy, allergen tablets, compliance, electronic compliance device
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electronic compliance device
Arm Type
Active Comparator
Arm Description
Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®)
Arm Title
No electronic compliance device
Arm Type
No Intervention
Arm Description
Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) without any electronic compliance device (Memozax®)
Intervention Type
Device
Intervention Name(s)
Electronic compliance device (Memozax®)
Intervention Description
An electronic compliance device is distributed to patients allocated to the active arm
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
up to 1 year per patient
Secondary Outcome Measure Information:
Title
Impact of GRAZAX® treatment on QoL as compared to previous season
Description
To evaluate after one-year treatment with Grazax tablets the impact on quality of life in comparison with previous pollen seasons
Time Frame
up to 1 year per patient
Title
Impact of GRAZAX® treatment on allergy symptoms as compared to previous season
Description
To evaluate after one-year treatment with Grazax tablets the impact on symptom score in comparison with previous pollen seasons
Time Frame
up to 1 year per patient
Title
Impact of GRAZAX® on treatment acceptance as compared to previous season
Description
To evaluate after one-year treatment with Grazax tablets the impact on patient's acceptance in comparison with previous pollen seasons
Time Frame
up to 1 year per patient
Title
Recording of all adverse events and serious adverse events
Description
The safety assessments included recording of all adverse events (AE) and serious adverse events (SAE) findings from physical examinations and from vital signs
Time Frame
up to 1 year per patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22131999
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.
Results Reference
result
Learn more about this trial
Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis
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