SUBLIVAC® Birch PROBE Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00932607
• Date of registration: 02/07/2009
• Prospective Registration: No
• Primary sponsor: HAL Allergy
• Public title: SUBLIVAC® Birch PROBE Study
• Scientific title: SUBLIVAC® Birch Prospective, Randomized, Open, Blinded Endpoint (PROBE) Study
• Date of first enrolment: July 2009
• Target sample size: 74
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00932607
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Oliver Pfaar, MD
• Affiliation: Zentrum für Rhinologie & Allergologie D-Wiesbaden

• Name: Ludger Klimek, PhD
• Affiliation: Zentrum für Rhinologie & Allergologie D-Wiesbaden

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Seasonal Rhinitis and/or Rhinoconjunctivitis

Birch Pollen Allergy

Intervention(s)

Drug: sublingual immunotherapy

Primary Outcome(s)

Difference in change of the titrated nasal provocation test (TNPT) between the two treatment groups [Time Frame: 16-20 weeks of treatment]

Secondary Outcome(s)

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]

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]

Immunoglobulins, changes in TNPT derived variables [Time Frame: 16-20 weeks of treatment]

Secondary ID(s)

SB/0027

Source(s) of Monetary Support

Please refer to primary and secondary sponsors