AllergyPhase 2NCT01191359
Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch
A Phase 2 study testing oral immunotherapy in people with Allergy, run by ALK-Abelló A/S at 1 site in Germany.
Trial summary
Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergy
- What is being tested?
- oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of Birch pollen allergy
- Positive skin prick test to birch
- Positive specific IgE to birch
Who cannot join
- Uncontrolled or severe asthma (FEV1<70% of predicted value in spite of adequate pharmacologic treatment)
- Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years
- Concomitant SLIT with any allergen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch
Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.
- Conditions
- Allergy
- Being tested
- oral immunotherapy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral immunotherapyBiological
Also called SLITone birch
orally applied specific immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| sublingual administration | Active comparator | oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose) Receives: Biological: oral immunotherapy |
| vestibular administration | Active comparator | oral immunotherapy with drops applied by single dose containers (200 STU per dose) Receives: Biological: oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch
specific antibody determination
Measured: after 4, 8, 12, 24, 36 weeks of treatment
Secondary outcomes (1)
Comparison of the two administration routes with regard to safety aspects
adverse events
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Bieber, MD, PhD, Principal investigator, Universitäsklinik Bonn, Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191359
- Sponsor's protocol ID
- SP-B-02
- Status last verified
- Feb 2013
- First submitted
- 27 Aug 2010
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch
- ClinicalTrials.gov ID
- NCT01191359
- Acronym / sponsor ID
- SP-B-02
- Conditions
- Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Aug 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.
Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sublingual administration | Active comparator | Biological: oral immunotherapyoral immunotherapy with drops applied once daily by single dose containers (200 STU per dose) |
| vestibular administration | Active comparator | Biological: oral immunotherapyoral immunotherapy with drops applied by single dose containers (200 STU per dose) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A history of Birch pollen allergy
- Positive skin prick test to birch
- Positive specific IgE to birch
Key exclusion criteria (3 listed)
- Uncontrolled or severe asthma (FEV1<70% of predicted value in spite of adequate pharmacologic treatment)
- Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years
- Concomitant SLIT with any allergen
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 |
|---|---|---|
| oral immunotherapyAlso: SLITone birchorally applied specific immunotherapy | Biological | sublingual administration, vestibular administration |
Primary outcome
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch
Time frame: after 4, 8, 12, 24, 36 weeks of treatment
specific antibody determination
1 secondary outcome
Comparison of the two administration routes with regard to safety aspects
Time frame: 36 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 Feb 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.
Thomas Bieber, MD, PhD principal investigator
Universitäsklinik Bonn, Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oral immunotherapy 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 3 inclusion and 3 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 Feb 2013. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch (time frame: after 4, 8, 12, 24, 36 weeks of treatment). 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 Feb 2013.