AllergyPhase 3NCT00408616
Efficacy and Safety of Grazax in Children
A Phase 3 study testing Grazax-R in people with Allergy, run by ALK-Abelló A/S at 1 site in Germany.
Trial summary
The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Allergy
- What is being tested?
- Grazax-R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Nov 2007
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys and girls 5-16 years of age
- A clinical history of grass pollen induced hayfever
- Positive Skin Prick Test to Phleum pratense
- Positive specific IgE against Phleum pratense
Who cannot join
- History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
- History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
- History of severe asthma
- Current severe atopic dermatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Trial Investigating the Efficacy and Safety of Grazax in Children Aged 5-16 Years With Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season
- Conditions
- Allergy
- Being tested
- Grazax-R, Grazax Placebo
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grazax-RBiological
Grass tablet, 75.000 SQ per day for one year
Grazax PlaceboBiological
Grazax Placebo, 0 SQ tablet per day for one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Grazax treatment Receives: Biological: Grazax-R |
| 2 | Placebo comparator | Grazax Placebo Receives: Biological: Grazax Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hayfever symptoms
Measured: Grass pollen season 2007
Intake of hayfever symptom relieving medication
Measured: Grass pollen season 2007
Secondary outcomes (6)
Combined hayfever symptom and medication scores
Measured: Grass pollen season 2007
Asthma symptoms and medication
Measured: Grass pollen season 2007
Global Evaluation of treatment efficacy
Measured: Grass pollen season 2007
Adverse Events
Measured: 9 months
Pharmacoeconomic Assessment
Measured: 9 months
Immunological Assessment
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionNov 2007
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 AllergyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Friedrich Kaiser, Dr. med., Principal investigator, Tangstedter Landstrasse 77, 22415 Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408616
- Sponsor's protocol ID
- GT-12
- Status last verified
- Mar 2009
- First submitted
- 6 Dec 2006
- Last updated
- 9 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B, Weisshaar C, Kaiser F. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 2009 Jan;123(1):167-173.e7. doi: 10.1016/j.jaci.2008.10.044.
PubMed 19130937
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial Investigating the Efficacy and Safety of Grazax in Children Aged 5-16 Years With Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma
- ClinicalTrials.gov ID
- NCT00408616
- Acronym / sponsor ID
- GT-12
- Conditions
- Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 7 Dec 2006 (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 investigate if immunotherapy with Grazax is safe and reduces the hayfever symptoms and the use of symptom relieving medications in children during the grass pollen season
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Grazax-RGrazax treatment |
| 2 | Placebo comparator | Biological: Grazax PlaceboGrazax Placebo |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Boys and girls 5-16 years of age
- A clinical history of grass pollen induced hayfever
- Positive Skin Prick Test to Phleum pratense
- Positive specific IgE against Phleum pratense
Key exclusion criteria (4 listed)
- History of seasonal hayfever symptoms (and/or asthma) caused by another allergen than Phleum pratense during or overlapping the grass pollen season
- History of perennial hayfever (and/or asthma) that needs medication due to an allergen to which the child is regularly exposed
- History of severe asthma
- Current severe atopic dermatitis
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 |
|---|---|---|
| Grazax-RGrass tablet, 75.000 SQ per day for one year | Biological | 1 |
| Grazax PlaceboGrazax Placebo, 0 SQ tablet per day for one year | Biological | 2 |
Primary outcome
Hayfever symptoms
Time frame: Grass pollen season 2007
Intake of hayfever symptom relieving medication
Time frame: Grass pollen season 2007
6 secondary outcomes
Combined hayfever symptom and medication scores
Time frame: Grass pollen season 2007
Asthma symptoms and medication
Time frame: Grass pollen season 2007
Global Evaluation of treatment efficacy
Time frame: Grass pollen season 2007
Adverse Events
Time frame: 9 months
Pharmacoeconomic Assessment
Time frame: 9 months
Immunological Assessment
Time frame: 9 months
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 9 Mar 2009.
- Results publication: PubMed 19130937Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, Knecht R, Stephan V, Tholstrup B, Weisshaar C, Kaiser F. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 2009 Jan;123(1):167-173.e7. doi: 10.1016/j.jaci.2008.10.044.
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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.
Friedrich Kaiser, Dr. med. principal investigator
Tangstedter Landstrasse 77, 22415 Hamburg, Germany
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-R in people with Allergy, run by ALK-Abelló A/S at 1 site in Germany.
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 4 inclusion and 4 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 9 Mar 2009. 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 Germany. 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?
Hayfever symptoms (time frame: Grass pollen season 2007). The study lists 2 primary outcomes in all. 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 NCT00408616, 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 9 Mar 2009.