Allergic RhinitisPhase 1NCT01719133
Skin Prick Tests With AllerT in Subjects Allergic to Birch Pollen
A Phase 1 study testing Histamine, AllerT1 and AllerT2 in people with Allergic Rhinitis, run by Anergis at 1 site in Switzerland.
Trial summary
Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Histamine, AllerT1 and AllerT2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2008to Jun 2008
- Phase
- Phase 1
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- history of allergy symptoms during previous birch pollen season
- positive skin prick test to birch pollen extract
Who cannot join
- pregnancy
- uncontrolled asthma
- other significant clinical conditions or immune disorders
- subjects taking antihistamines or drugs with antihistamine activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1
Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.
Read the detailed description
The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter > 4 mm with erythema)
- Conditions
- Allergic Rhinitis
- Being tested
- placebo, Histamine, AllerT1, AllerT2, AllerT3
- Keywords
- allergy, birch
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called saline
saline solution
HistamineDrug
Also called Histamine solution
positive control
AllerT1Drug
synthetic peptide T1
AllerT2Drug
synthetic peptide T2
AllerT3Drug
synthetic peptide T3
AllerT4Drug
synthetic peptide T4
AllerT5Drug
synthetic peptide T5
mix of AllerT1-T2-T3Drug
Also called AllerT
mix of peptides T1, T2 and T3
mix of AllerT4-T5Drug
Also called mix T4-T5
mix T4-T5
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5 Receives: Drug: placebo; Drug: Histamine; Drug: AllerT1; Drug: AllerT2; Drug: AllerT3; Drug: AllerT4; Drug: AllerT5; Drug: mix of AllerT1-T2-T3; Drug: mix of AllerT4-T5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin prick test reactivity
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionJun 2008
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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anergis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francois Spertini, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719133
- Sponsor's protocol ID
- AN002
- Status last verified
- Oct 2012
- First submitted
- 26 Oct 2012
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pellaton C, Perrin Y, Boudousquie C, Barbier N, Wassenberg J, Corradin G, Thierry AC, Audran R, Reymond C, Spertini F. Novel birch pollen specific immunotherapy formulation based on contiguous overlapping peptides. Clin Transl Allergy. 2013 Jun 1;3(1):17. doi: 10.1186/2045-7022-3-17.
PubMed 23725004
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Détermination de la réactivité cutanée de Volontaires Allergiques au Pollen de Bouleau Contre Des Peptides dérivés de Bet v 1
- ClinicalTrials.gov ID
- NCT01719133
- Acronym / sponsor ID
- AN002
- Conditions
- Allergic Rhinitis
- Keywords
- allergy, birch
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AnergisIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 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.
Assessment of skin reactivity by skin prick tests to synthetic peptides derived from the major birch allergen bet v 1, in subjects allergic to birch pollen.
Detailed description
The study tested - all by skin tests - in the same group of 20 trial subjects, one positive control (histamine solution), one negative control (placebo saline) and five experimental peptides called T1, T2, T3, T4 and T5. Results of the skin prick tests were scored as negative (no reaction) or positive (wheal diameter > 4 mm with erythema)
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Drug: placebo, Drug: Histamine, Drug: AllerT1, Drug: AllerT2, Drug: AllerT3, Drug: AllerT4, Drug: AllerT5, Drug: mix of AllerT1-T2-T3, Drug: mix of AllerT4-T5placebo histamine T1 T2 T3 T4 T5 T1-T2-T3 T4-T5 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- history of allergy symptoms during previous birch pollen season
- positive skin prick test to birch pollen extract
Key exclusion criteria (4 listed)
- pregnancy
- uncontrolled asthma
- other significant clinical conditions or immune disorders
- subjects taking antihistamines or drugs with antihistamine activity
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 |
|---|---|---|
| placeboAlso: salinesaline solution | Drug | All subjects |
| HistamineAlso: Histamine solutionpositive control | Drug | All subjects |
| AllerT1synthetic peptide T1 | Drug | All subjects |
| AllerT2synthetic peptide T2 | Drug | All subjects |
| AllerT3synthetic peptide T3 | Drug | All subjects |
| AllerT4synthetic peptide T4 | Drug | All subjects |
| AllerT5synthetic peptide T5 | Drug | All subjects |
| mix of AllerT1-T2-T3Also: AllerTmix of peptides T1, T2 and T3 | Drug | All subjects |
| mix of AllerT4-T5Also: mix T4-T5mix T4-T5 | Drug | All subjects |
Primary outcome
skin prick test reactivity
Time frame: 15 minutes
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 1 Nov 2012.
- Derived from this study: PubMed 23725004Pellaton C, Perrin Y, Boudousquie C, Barbier N, Wassenberg J, Corradin G, Thierry AC, Audran R, Reymond C, Spertini F. Novel birch pollen specific immunotherapy formulation based on contiguous overlapping peptides. Clin Transl Allergy. 2013 Jun 1;3(1):17. doi: 10.1186/2045-7022-3-17.
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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.
Francois Spertini, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Histamine, AllerT1 and AllerT2 in people with Allergic Rhinitis, run by Anergis at 1 site in Switzerland.
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 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 1 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 Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 prick test reactivity (time frame: 15 minutes). 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 NCT01719133, 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 1 Nov 2012.