Allergic RhinoconjunctivitisPhase 4GRAALNCT01433510
Tolerability of Grazax in Patients With Hayfever in Real Life Settings
A Phase 4 study testing Grazax in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in France.
Trial summary
The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Grazax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Dec 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of grass pollen allergy
- Positive skin prick-test and/or positive specific IgE to grass
Who cannot join
- Severe, unstable or uncontrolled asthma (FEV1<70% of predicted value)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings
The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.
Read the detailed description
To assess the safety profile with Grazax according to the presence or not of polysensitization and/or asthma at enrollment
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Grazax
- Keywords
- Allergic, Rhinoconjunctivitis, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrazaxDrug
1 tablet/day - pre and co-seasonal
| Study group | Role | What they receive |
|---|---|---|
| Grazax Tablets 75000 SQT | Experimental | Timothy Extract Receives: Drug: Grazax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events related to Grazax
All adverse events were reported according to the MedDRA dictionary
Measured: From November 2007 to October 2010 (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startNov 2007
- Primary completionOct 2010
- Study completionDec 2010
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 RhinoconjunctivitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François FW Wessel, MD, Principal investigator, Centre Hospitalier Universitaire F-44000 Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433510
- Sponsor's protocol ID
- GT-15
- Other IDs
- 2007-003772-20
- Acronym
- GRAAL
- Status last verified
- May 2024
- First submitted
- 12 Sep 2011
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Wessel F, Chartier A, Meunier JP, Magnan A. Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX(R)) in a real-life setting for three consecutive seasons - the GRAAL trial. Clin Drug Investig. 2012 Jul 1;32(7):451-63. doi: 10.2165/11634270-000000000-00000.
PubMed 22594491
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational National Clinical Trial of Safety and Tolerance in Patients Suffering of an Allergic Grass Pollen Rhinitis and Treated by Grazax in Real Life Settings
- ClinicalTrials.gov ID
- NCT01433510
- Acronym / sponsor ID
- GRAAL / GT-15
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- Allergic, Rhinoconjunctivitis, Immunotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Sep 2011 (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.
The purpose of this study is to assess the safety profile of specific immunotherapy with Grazax for three consecutive grass pollen seasons.
Detailed description
To assess the safety profile with Grazax according to the presence or not of polysensitization and/or asthma at enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grazax Tablets 75000 SQT | Experimental | Drug: GrazaxTimothy Extract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of grass pollen allergy
- Positive skin prick-test and/or positive specific IgE to grass
Key exclusion criteria (1 listed)
- Severe, unstable or uncontrolled asthma (FEV1<70% of predicted value)
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 |
|---|---|---|
| Grazax1 tablet/day - pre and co-seasonal | Drug | Grazax Tablets 75000 SQT |
Primary outcome
Adverse Events related to Grazax
Time frame: From November 2007 to October 2010 (3 years)
All adverse events were reported according to the MedDRA dictionary
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 29 May 2024.
- Derived from this study: PubMed 22594491Wessel F, Chartier A, Meunier JP, Magnan A. Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX(R)) in a real-life setting for three consecutive seasons - the GRAAL trial. Clin Drug Investig. 2012 Jul 1;32(7):451-63. doi: 10.2165/11634270-000000000-00000.
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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.
François FW Wessel, MD principal investigator
Centre Hospitalier Universitaire F-44000 Nantes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Grazax in people with Allergic Rhinoconjunctivitis, run by ALK-Abelló A/S at 1 site in France.
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 2 inclusion and 1 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 29 May 2024. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Adverse Events related to Grazax (time frame: From November 2007 to October 2010 (3 years)). 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 NCT01433510, 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 29 May 2024.