Rhinitis, Allergic, SeasonalPhase 1NCT01224834
Safety and Tolerability Study of Ragweed SLIT Tablets
A Phase 1 study testing Sublingual tablet of ragweed pollen allergen extract in people with Rhinitis, Allergic, Seasonal and Ragweed Pollen Allergy, run by Stallergenes Greer at 1 site in Hungary.
Trial summary
The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Ragweed Pollen Allergy
- What is being tested?
- Sublingual tablet of ragweed pollen allergen extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- Jan 2009to Oct 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- written consent
- male or female subjects from 18 yo 60 years old and in general good health
- for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
- symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
- sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening
- FEV1 at least of 80% of predicted value at screening
Who cannot join
- past or current disease which, as judged by the investigator, may affect the outcome of this study
- history of life-threatening asthma
- asthma requiring daily treatment (whatever the pharmaceutical class)
- pregnant or lactating women
- subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study
- symptoms during the treatment phase due to a sensitivity to a second allergen
- subjects treated with ongoing immunotherapy with another allergen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets Given in Single Rising Doses and in Multi Dose Regimens to Subjects With an Allergy to Ragweed Pollen.
The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.
- Being tested
- Sublingual tablet of ragweed pollen allergen extract
- Keywords
- Ragweed, allergy, sublingual immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual tablet of ragweed pollen allergen extractDrug
administered once a day over 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Sublingual tablet of ragweed pollen allergen extract |
| 2 | Experimental | Not described Receives: Drug: Sublingual tablet of ragweed pollen allergen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks
Measured: 2 weeks
Secondary outcomes (1)
Immunological markers (IgE and IgG4)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- Eva Péterfai, MD, Principal investigator, DRC Drug Research Center, Balatonfüred - Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224834
- Sponsor's protocol ID
- VO63.08 HUN
- Status last verified
- Oct 2010
- First submitted
- 13 Oct 2010
- Last updated
- 8 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets Given in Single Rising Doses and in Multi Dose Regimens to Subjects With an Allergy to Ragweed Pollen.
- ClinicalTrials.gov ID
- NCT01224834
- Acronym / sponsor ID
- VO63.08 HUN
- Keywords
- Ragweed, allergy, sublingual immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 20 Oct 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.
The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Sublingual tablet of ragweed pollen allergen extract |
| 2 | Experimental | Drug: Sublingual tablet of ragweed pollen allergen extract |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- written consent
- male or female subjects from 18 yo 60 years old and in general good health
- for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
- symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
- sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening
Key exclusion criteria (7 listed)
- past or current disease which, as judged by the investigator, may affect the outcome of this study
- history of life-threatening asthma
- asthma requiring daily treatment (whatever the pharmaceutical class)
- pregnant or lactating women
- subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study
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 |
|---|---|---|
| Sublingual tablet of ragweed pollen allergen extractadministered once a day over 10 days | Drug | 1, 2 |
Primary outcome
Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks
Time frame: 2 weeks
1 secondary outcome
Immunological markers (IgE and IgG4)
Time frame: 2 weeks
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 Nov 2010.
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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.
Eva Péterfai, MD principal investigator
DRC Drug Research Center, Balatonfüred - Hungary
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 Sublingual tablet of ragweed pollen allergen extract in people with Rhinitis, Allergic, Seasonal and Ragweed Pollen Allergy, run by Stallergenes Greer at 1 site in Hungary.
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 6 inclusion and 7 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 Nov 2010. 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 Hungary. 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 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?
Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks (time frame: 2 weeks). 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 Nov 2010.