AllergyPhase 3NCT01964768
Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing
A Phase 3 study testing Skin prick-test in people with Allergy, run by Stallergenes Greer.
Trial summary
A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test: 5 Grasses pollen, Birch pollen, Dermatophagoides pteronyssinus mite Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Allergy
- What is being tested?
- Skin prick-test
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Feb 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent to participate in the study
- Male or female subjects aged 5-60 years inclusive
- Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test
- Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years)
- Subjects affiliated to a social security system
Who cannot join
- Pregnant or breastfeeding women
- Dermographism
- Absence of cutaneous reactivity
- Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test
- Subjects presenting unstable asthma or poor general health condition
- Subjects with past or current specific immunotherapy treatment for any of the 3 tested allergens (Grass, Birch pollens, D. pteronyssinus and/or D. farinae mites) in the previous 5 years
Show all 12Show fewer
- Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine
- Subjects on anti-IgE treatment
- Subjects treated with beta-blockers and/or anti-depressives.
- Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial
- Investigators, co-investigators, as well as their children or spouses and all the study collaborators
- Subjects under protection of the courts, legal guardianship or legal trusteeship
About this study
Official title: Determination of Sensitivity and Specificity of Three Solutions of Allergen Extract (5 Grasses, Birch Pollens and Dermatophagoides Pteronyssinus Mites) for Diagnosis by Skin Prick Testing
A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test:
- 5 Grasses pollen,
- Birch pollen,
- Dermatophagoides pteronyssinus mite
- Conditions
- Allergy
- Being tested
- Skin prick-test
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin prick-testOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative.
Measured: For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination.
Secondary outcomes (1)
One of the secondary measurement was the wheal diameter for each allergen.
Measured: SPT measurements were performed after the study visit, an expected average of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric de Blay, Pr, Principal investigator, Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964768
- Sponsor's protocol ID
- DG40.08
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Sensitivity and Specificity of Three Solutions of Allergen Extract (5 Grasses, Birch Pollens and Dermatophagoides Pteronyssinus Mites) for Diagnosis by Skin Prick Testing
- ClinicalTrials.gov ID
- NCT01964768
- Acronym / sponsor ID
- DG40.08
- Conditions
- Allergy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 17 Oct 2013 (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.
A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test:
- 5 Grasses pollen,
- Birch pollen,
- Dermatophagoides pteronyssinus mite
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Written informed consent to participate in the study
- Male or female subjects aged 5-60 years inclusive
- Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test
- Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years)
- Subjects affiliated to a social security system
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women
- Dermographism
- Absence of cutaneous reactivity
- Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test
- Subjects presenting unstable asthma or poor general health condition
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 |
|---|---|---|
| Skin prick-test | Other | – |
Primary outcome
Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative.
Time frame: For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination.
1 secondary outcome
One of the secondary measurement was the wheal diameter for each allergen.
Time frame: SPT measurements were performed after the study visit, an expected average of 1 week.
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 17 Oct 2013.
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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.
Frédéric de Blay, Pr principal investigator
Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Skin prick-test in people with Allergy, run by Stallergenes Greer.
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 5 inclusion and 12 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 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative. (time frame: For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination.). 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 17 Oct 2013.