Seasonal Allergic RhinoconjunctivitisPhase 1NCT00813046
Safety and Tolerance Study of Grass Pollen-derived Peptides to Treat Allergic Rhinitis
A Phase 1 study testing gpASIT+TM in people with Seasonal Allergic Rhinoconjunctivitis, run by BioTech Tools S.A. at 1 site in Belgium.
Trial summary
The purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Seasonal Allergic Rhinoconjunctivitis
- What is being tested?
- gpASIT+TM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2008to Jan 2009
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- Male or non-pregnant, non-lactating females
- A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the last two years
- A positive skin prick test to grass-pollen mixture
- Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l)
- Asymptomatic to perennial inhalant allergens
Who cannot join
- Subjects with current or past immunotherapy for SAR
- Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
- Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)
- Subjects with a history of food allergy and consecutive anaphylaxis
- Subjects with a history of hepatic or renal disease
- Subject with malignant disease, autoimmune disease
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- Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD).
- Females unable to bear children must have documentation of such (i.e. tubal ligation, hysterectomy, or post menopausal [defined as a minimum of one year since the last menstrual period])
- Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…)
- Subjects with clinically relevant abnormal QTc intervals of the ECG : QTc > 450 ms for man and > 470 ms for women
- Subjects requiring beta-blockers medication
- Chronic use of concomitant medications that would affect assessment of the effectiveness of the study medication (e.g. tricyclic antidepressants)
- Subject with febrile illness (> 37.5°C, oral)
- A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
- The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry
- Receipt of blood or a blood derivative in the past 6 months preceding study entry
- Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the study, any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the study
- Use of long-acting antihistamines
- Any condition which could be incompatible with protocol understanding and compliance
- Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship,
- Participation in another clinical trial and/or treatment with an experimental drug within 1 month of study start
- A history of hypersensitivity to the excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Assessment of the Short Term Clinical Tolerability and Safety of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis
The purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.
- Conditions
- Seasonal Allergic Rhinoconjunctivitis
- Being tested
- gpASIT+TM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gpASIT+TMBiological
oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days
| Study group | Role | What they receive |
|---|---|---|
| gpASIT+TM | Experimental | Not described Receives: Biological: gpASIT+TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction.
Measured: 10 days
Secondary outcomes (1)
vital signs clinical laboratory evaluations adverse events general physical status
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTech Tools S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813046
- Sponsor's protocol ID
- BTT-gpASIT002
- Other IDs
- EudraCT 2008-006368-12
- Status last verified
- May 2014
- First submitted
- 19 Dec 2008
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Assessment of the Short Term Clinical Tolerability and Safety of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00813046
- Acronym / sponsor ID
- BTT-gpASIT002
- Conditions
- Seasonal Allergic Rhinoconjunctivitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BioTech Tools S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Dec 2008 (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 determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gpASIT+TM | Experimental | Biological: gpASIT+TM |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 50 years
- The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- Male or non-pregnant, non-lactating females
- A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the last two years
- A positive skin prick test to grass-pollen mixture
Key exclusion criteria (22 listed)
- Subjects with current or past immunotherapy for SAR
- Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
- Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)
- Subjects with a history of food allergy and consecutive anaphylaxis
- Subjects with a history of hepatic or renal disease
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 |
|---|---|---|
| gpASIT+TMoral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days | Biological | gpASIT+TM |
Primary outcome
To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction.
Time frame: 10 days
1 secondary outcome
vital signs clinical laboratory evaluations adverse events general physical status
Time frame: 10 days
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 26 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 gpASIT+TM in people with Seasonal Allergic Rhinoconjunctivitis, run by BioTech Tools S.A. at 1 site in Belgium.
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 7 inclusion and 22 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 26 May 2014. 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 Belgium. 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?
To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction. (time frame: 10 days). 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 26 May 2014.