Back to resultsSUBLIVAC® Birch PROBE Study
Primary Purpose
Seasonal Rhinitis and/or Rhinoconjunctivitis, Birch Pollen Allergy
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
sublingual immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Rhinitis and/or Rhinoconjunctivitis focused on measuring seasonal, rhinitis, rhinoconjunctivitis, birch pollen, immunotherapy, sublingual
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Zentrum für Rhinologie & Allergologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Staloral Birch
SUBLIVAC Birch
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Difference in change of the titrated nasal provocation test (TNPT) between the two treatment groups
Secondary Outcome Measures
Immunoglobulins, changes in TNPT derived variables
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00932607
Brief Title
SUBLIVAC® Birch PROBE Study
Official Title
SUBLIVAC® Birch Prospective, Randomized, Open, Blinded Endpoint (PROBE) Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HAL Allergy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Rhinitis and/or Rhinoconjunctivitis, Birch Pollen Allergy
Keywords
seasonal, rhinitis, rhinoconjunctivitis, birch pollen, immunotherapy, sublingual
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Staloral Birch
Arm Type
Active Comparator
Arm Description
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).
Arm Title
SUBLIVAC Birch
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
sublingual immunotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Difference in change of the titrated nasal provocation test (TNPT) between the two treatment groups
Time Frame
16-20 weeks of treatment
Secondary Outcome Measure Information:
Title
Immunoglobulins, changes in TNPT derived variables
Time Frame
16-20 weeks of treatment
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludger Klimek, PhD
Organizational Affiliation
Zentrum für Rhinologie & Allergologie D-Wiesbaden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oliver Pfaar, MD
Organizational Affiliation
Zentrum für Rhinologie & Allergologie D-Wiesbaden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zentrum für Rhinologie & Allergologie
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
D-65183
Country
Germany
12. IPD Sharing Statement
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SUBLIVAC® Birch PROBE Study
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