Allergic RhinitisPhase 3GT-17NCT01728285
Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis
A Phase 3 study testing Electronic compliance device (Memozax®) in people with Allergic Rhinitis and Grass Allergy, run by ALK-Abelló A/S at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Grass Allergy
- What is being tested?
- Electronic compliance device (Memozax®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Oct 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Electronic compliance device (Memozax®)
- Keywords
- specific allergen immunotherapy, sublingual immunotherapy, allergen tablets, compliance, electronic compliance device
- Medical subject headings
- Rhinitis, Allergic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic compliance device (Memozax®)Device
An electronic compliance device is distributed to patients allocated to the active arm
| Study group | Role | What they receive |
|---|---|---|
| Electronic compliance device | Active comparator | Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an electronic compliance device (Memozax®) Receives: 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®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year per patient
Secondary outcomes (4)
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
Measured: up to 1 year per patient
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
Measured: up to 1 year per patient
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
Measured: up to 1 year per patient
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
Measured: up to 1 year per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2012 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728285
- Sponsor's protocol ID
- GT-17 ITALY
- Other IDs
- 2006-004820-35
- Acronym
- GT-17
- Status last verified
- Nov 2012
- First submitted
- 2 Nov 2012
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22131999
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01728285
- Acronym / sponsor ID
- GT-17 / GT-17 ITALY
- Conditions
- Allergic Rhinitis, Grass Allergy
- Keywords
- specific allergen immunotherapy, sublingual immunotherapy, allergen tablets, compliance, electronic compliance device
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic compliance device | Active comparator | Device: Electronic compliance device (Memozax®)Patients with grass allergy treated with allergen specific immunotherapy (GRAZAX®) using an 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®) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic compliance device (Memozax®)An electronic compliance device is distributed to patients allocated to the active arm | Device | Electronic compliance device |
Primary outcome
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
4 secondary outcomes
Impact of GRAZAX® treatment on QoL as compared to previous season
Time frame: 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
Impact of GRAZAX® on treatment acceptance as compared to previous season
Time frame: up to 1 year per patient
Recording of all adverse events and serious adverse events
Time frame: up to 1 year per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
- Results publication: PubMed 22131999Alesina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electronic compliance device (Memozax®) in people with Allergic Rhinitis and Grass Allergy, run by ALK-Abelló A/S at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01728285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2012.