Seasonal Rhinitis and/or RhinoconjunctivitisPhase 2NCT00932607
SUBLIVAC® Birch PROBE Study
A Phase 2 study testing sublingual immunotherapy in people with Seasonal Rhinitis and/or Rhinoconjunctivitis and Birch Pollen Allergy, run by HAL Allergy at 1 site in Germany.
Trial summary
Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC Birch is also effective compared to treatment with Staloral Birch by means of reduction in allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic complaints triggered by birch pollen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Rhinitis and/or Rhinoconjunctivitis, Birch Pollen Allergy
- What is being tested?
- sublingual immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Feb 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 ≥ 70%) due to birch pollen for at least 2 years.
- Use of anti-allergy symptomatic medication in the last birch pollen season (in case of a season with low pollen counts, in one of the two previous years).
- No seasonal allergic complaints induced by birch, grasses or mugwort pollen for at least 4 weeks in the absence of rescue medication during at least the last 2 weeks before the baseline.
- A positive SPT (diameter ≥3 mm) for birch pollen and a positive specific serum anti birch IgE-test (>1 U/ml).
- A positive TNPT with a birch allergen extract containing a concentration of 10, 100 or 1000 AU/ml at the baseline visit.
- Age 18 years and older.
- Subjects shall give a written informed consent.
Who cannot join
- A positive SPT (diameter ≥ 3mm) for hazel or alder and the maintenance dose will not be reached before 8 October 2009.
- A positive SPT (diameter ≥ 3mm) for pets and symptoms related to concomitant sensitization to pets while having these animals at home.
- A positive SPT (diameter ≥ 3mm) for house dust mite or moulds and clinically relevant symptoms related to concomitant sensitization to house dust mite or moulds, based on the investigator's research (TNPT for example).
- Allergy to any of the excipients of SUBLIVAC Birch or Staloral Birch.
- Chronic asthma or emphysema, particularly with an FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days.
- Specific findings for nose and mouth at screening or rhinoscopy before TNPT.
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- Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
- Inflammation or infection of the target organ (nose, eyes and lungs).
- Severe atopic dermatitis requiring systemic immuno-suppressive medication.
- Allergen specific immunotherapy treatment for a period longer than 3 months within the last 5 years.
- History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
- A positive pregnancy test, lactation or inadequate contraceptive measures. (adequate measures: oral contraceptives, IUD, condom use and having no sexual relationship with a man)
- Alcohol- or drug abuse.
- Lack of co-operation or severe psychological disorders.
- Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
- Low compliance or inability to understand instructions/study documents
- Completed or ongoing treatment with anti-IgE-antibody
- Patients being in any relationship or dependence with the sponsor or investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SUBLIVAC® Birch Prospective, Randomized, Open, Blinded Endpoint (PROBE) Study
Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC Birch is also effective compared to treatment with Staloral Birch by means of reduction in allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic complaints triggered by birch pollen.
- Being tested
- sublingual immunotherapy
- Keywords
- seasonal, rhinitis, rhinoconjunctivitis, birch pollen, immunotherapy, sublingual
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sublingual immunotherapyDrug
Start with 1 drop daily of SUBLIVAC Birch and increase by 1 drop daily, until the maintenance dose of 5 drops is reached. This maintenance dose should then be taken daily. Or 1 puff of Staloral Birch 10 I.R./ml on day one, 2 puffs on day two and increase by 2 puffs until at day six 10 puffs are reached. At day seven 1 puff of Staloral Birch 300 I.R./ml is taken, at day eight 2 puffs and day nine 4 puffs. From then on 4 puffs daily are taken.
Route of administration: Sublingual application. Drops (for SUBLIVAC Birch) or puffs (for Staloral Birch) are to be held underneath the tongue and then will be swallowed.
Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy).
| Study group | Role | What they receive |
|---|---|---|
| Staloral Birch | Active comparator | Start with 1 puff of Staloral Birch 10 I.R./ml on day one, 2 puffs on day two and increase by 2 puffs until at day six 10 puffs are reached. At day seven 1 puff of Staloral Birch 300 I.R./ml is taken, at day eight 2 puffs and day nine 4 puffs. From then on 4 puffs daily are taken.
Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy). Receives: Drug: sublingual immunotherapy |
| SUBLIVAC Birch | Experimental | Start with 1 drop daily of SUBLIVAC Birch and increase by 1 drop daily, until the maintenance dose of 5 drops is reached. This maintenance dose should then be taken daily.
Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy). Receives: Drug: sublingual immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change of the titrated nasal provocation test (TNPT) between the two treatment groups
Measured: 16-20 weeks of treatment
Secondary outcomes (3)
Immunoglobulins, changes in TNPT derived variables
Measured: 16-20 weeks of treatment
Determination of specific IgE and specific IgG to birch at the baseline and the end of study. It is expected that changes in specific IgE and IgG will be equal in both treatment groups
Measured: 16-20 weeks of treatment
At the baseline and the end of study visit the subject will be asked questions for the evaluation of oral allergy syndrome. It is expected that the reduction of oral allergy syndrome complaints will be equal in both treatment groups.
Measured: 16-20 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Rhinitis and/or 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludger Klimek, PhD, Study chair, Zentrum für Rhinologie & Allergologie D-WiesbadenOliver Pfaar, MD, Principal investigator, Zentrum für Rhinologie & Allergologie D-Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932607
- Sponsor's protocol ID
- SB/0027
- Status last verified
- Feb 2012
- First submitted
- 2 Jul 2009
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUBLIVAC® Birch Prospective, Randomized, Open, Blinded Endpoint (PROBE) Study
- ClinicalTrials.gov ID
- NCT00932607
- Acronym / sponsor ID
- SB/0027
- Keywords
- seasonal, rhinitis, rhinoconjunctivitis, birch pollen, immunotherapy, sublingual
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- First posted
- 3 Jul 2009 (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.
Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC Birch is also effective compared to treatment with Staloral Birch by means of reduction in allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic complaints triggered by birch pollen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staloral Birch | Active comparator | Drug: sublingual immunotherapyStart with 1 puff of Staloral Birch 10 I.R./ml on day one, 2 puffs on day two and increase by 2 puffs until at day six 10 puffs are reached. At day seven 1 puff of Staloral Birch 300 I.R./ml is taken, at day eight 2 puffs and day nine 4 puffs. From then on 4 puffs daily are taken. Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy). |
| SUBLIVAC Birch | Experimental | Drug: sublingual immunotherapyStart with 1 drop daily of SUBLIVAC Birch and increase by 1 drop daily, until the maintenance dose of 5 drops is reached. This maintenance dose should then be taken daily. Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with allergic rhinoconjunctivitis with or without mild asthma (FEV1 ≥ 70%) due to birch pollen for at least 2 years.
- Use of anti-allergy symptomatic medication in the last birch pollen season (in case of a season with low pollen counts, in one of the two previous years).
- No seasonal allergic complaints induced by birch, grasses or mugwort pollen for at least 4 weeks in the absence of rescue medication during at least the last 2 weeks before the baseline.
- A positive SPT (diameter ≥3 mm) for birch pollen and a positive specific serum anti birch IgE-test (>1 U/ml).
- A positive TNPT with a birch allergen extract containing a concentration of 10, 100 or 1000 AU/ml at the baseline visit.
Key exclusion criteria (18 listed)
- A positive SPT (diameter ≥ 3mm) for hazel or alder and the maintenance dose will not be reached before 8 October 2009.
- A positive SPT (diameter ≥ 3mm) for pets and symptoms related to concomitant sensitization to pets while having these animals at home.
- A positive SPT (diameter ≥ 3mm) for house dust mite or moulds and clinically relevant symptoms related to concomitant sensitization to house dust mite or moulds, based on the investigator's research (TNPT for example).
- Allergy to any of the excipients of SUBLIVAC Birch or Staloral Birch.
- Chronic asthma or emphysema, particularly with an FEV1 < 70 % of predicted value or use of inhalation corticosteroids outside grass and tree pollen season for more than two episodes and/or longer than fourteen days.
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 immunotherapyStart with 1 drop daily of SUBLIVAC Birch and increase by 1 drop daily, until the maintenance dose of 5 drops is reached. This maintenance dose should then be taken daily. Or 1 puff of Staloral Birch 10 I.R./ml on day one, 2 puffs on day two and increase by 2 puffs until at day six 10 puffs are reached. At day seven 1 puff of Staloral Birch 300 I.R./ml is taken, at day eight 2 puffs and day nine 4 puffs. From then on 4 puffs daily are taken. Route of administration: Sublingual application. Drops (for SUBLIVAC Birch) or puffs (for Staloral Birch) are to be held underneath the tongue and then will be swallowed. Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy). | Drug | SUBLIVAC Birch, Staloral Birch |
Primary outcome
Difference in change of the titrated nasal provocation test (TNPT) between the two treatment groups
Time frame: 16-20 weeks of treatment
3 secondary outcomes
Immunoglobulins, changes in TNPT derived variables
Time frame: 16-20 weeks of treatment
Determination of specific IgE and specific IgG to birch at the baseline and the end of study. It is expected that changes in specific IgE and IgG will be equal in both treatment groups
Time frame: 16-20 weeks of treatment
At the baseline and the end of study visit the subject will be asked questions for the evaluation of oral allergy syndrome. It is expected that the reduction of oral allergy syndrome complaints will be equal in both treatment groups.
Time frame: 16-20 weeks of treatment
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 7 Feb 2012.
Related trials for Seasonal Rhinitis and/or Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
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.
Ludger Klimek, PhD study chair
Zentrum für Rhinologie & Allergologie D-Wiesbaden
Oliver Pfaar, MD principal investigator
Zentrum für Rhinologie & Allergologie D-Wiesbaden
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 sublingual immunotherapy in people with Seasonal Rhinitis and/or Rhinoconjunctivitis and Birch Pollen Allergy, run by HAL Allergy 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 7 inclusion and 18 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 7 Feb 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 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?
Difference in change of the titrated nasal provocation test (TNPT) between the two treatment groups (time frame: 16-20 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 7 Feb 2012; AzTrials last refreshed its copy on 27 Oct 2026.