Allergic RhinitisPhase 3GAPNCT01061203
Grazax Asthma Prevention
A Phase 3 study testing Grazax in people with Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in Finland.
Trial summary
Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Grazax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 812 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2010to Sep 2015
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A history of grass pollen allergy
- Positive Skin prick test to grass
- Positive specific IgE to grass
Who cannot join
- Asthma
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy
Read the detailed description
Investigation of the effect of Grazax (ALK produced grass tablet) on asthma prevention in children with grass pollen allergy.
Children in the age of 6-12 years will be randomised to either placebo or Grazax treatment. Grazax has been approved for treatment of grass pollen allergy in adults and children, diagnosed with a positive skin prick test and/or specific immunoglobulin (IgE) test to grass pollen and with clinically relevant symptoms. This study will explore prevention of asthma in children with grass pollen induced allergy.
- Conditions
- Allergic Rhinitis
- Being tested
- Grazax, Placebo
- Keywords
- Rhinitis, allergic, Seasonal, grass, Asthma
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrazaxDrug
Treatment with 75.000 SQ-T once daily
PlaceboDrug
Tablet with no active grass component.
| Study group | Role | What they receive |
|---|---|---|
| Grazax | Active comparator | Grazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue. Receives: Drug: Grazax |
| Tablet with no active grass | Placebo comparator | Tablet with no active grass component. One tablet per day administered under the tongue. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of allergy and asthma symptoms
Measured: 5 years
Secondary outcomes (1)
Quality of life and adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erkka Valovirta, MD, Principal investigator, Terveystalo Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061203
- Sponsor's protocol ID
- GT-21
- Acronym
- GAP
- Status last verified
- Sep 2016
- First submitted
- 1 Feb 2010
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grazax Asthma Prevention
- ClinicalTrials.gov ID
- NCT01061203
- Acronym / sponsor ID
- GAP / GT-21
- Conditions
- Allergic Rhinitis
- Keywords
- Rhinitis, allergic, Seasonal, grass, Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Feb 2010 (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.
Investigation of the effect of Grazax (grass tablet) on asthma prevention in children with grass pollen allergy
Detailed description
Investigation of the effect of Grazax (ALK produced grass tablet) on asthma prevention in children with grass pollen allergy.
Children in the age of 6-12 years will be randomised to either placebo or Grazax treatment. Grazax has been approved for treatment of grass pollen allergy in adults and children, diagnosed with a positive skin prick test and/or specific immunoglobulin (IgE) test to grass pollen and with clinically relevant symptoms. This study will explore prevention of asthma in children with grass pollen induced allergy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grazax | Active comparator | Drug: GrazaxGrazax tablet 75.000 SQ-T. One tablet per day for administration under the tongue. |
| Tablet with no active grass | Placebo comparator | Drug: PlaceboTablet with no active grass component. One tablet per day administered under the tongue. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A history of grass pollen allergy
- Positive Skin prick test to grass
- Positive specific IgE to grass
Key exclusion criteria (1 listed)
- Asthma
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 |
|---|---|---|
| GrazaxTreatment with 75.000 SQ-T once daily | Drug | Grazax |
| PlaceboTablet with no active grass component. | Drug | Tablet with no active grass |
Primary outcome
Evaluation of allergy and asthma symptoms
Time frame: 5 years
1 secondary outcome
Quality of life and adverse events
Time frame: 5 years
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 8 Sep 2016.
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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.
Erkka Valovirta, MD principal investigator
Terveystalo Turku, Finland
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 Grazax in people with Allergic Rhinitis, run by ALK-Abelló A/S at 1 site in Finland.
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 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 8 Sep 2016. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
Evaluation of allergy and asthma symptoms (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2016.