SUBLIVAC® Birch PROBE Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Seasonal Rhinitis and/or Rhinoconjunctivitis Birch Pollen Allergy	Drug: sublingual immunotherapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	SUBLIVAC® Birch Prospective, Randomized, Open, Blinded Endpoint (PROBE) Study

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

U.S. FDA Resources

Further study details as provided by HAL Allergy:

Primary Outcome Measures:

Difference in change of the titrated nasal provocation test (TNPT) between the two treatment groups [ Time Frame: 16-20 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunoglobulins, changes in TNPT derived variables [ Time Frame: 16-20 weeks of treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	74
Study Start Date:	July 2009
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Staloral Birch 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).	Drug: sublingual immunotherapy 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).
Experimental: SUBLIVAC Birch 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).	Drug: sublingual immunotherapy 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).

Arms

Assigned Interventions

Active Comparator: Staloral Birch

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).

Drug: sublingual immunotherapy

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).

Experimental: SUBLIVAC Birch

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).

Drug: sublingual immunotherapy

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932607

Locations

Germany
Zentrum für Rhinologie & Allergologie
Wiesbaden, Hessen, Germany, D-65183

Sponsors and Collaborators

HAL Allergy

Investigators

Study Chair:	Ludger Klimek, PhD	Zentrum für Rhinologie & Allergologie D-Wiesbaden
Principal Investigator:	Oliver Pfaar, MD	Zentrum für Rhinologie & Allergologie D-Wiesbaden

More Information

No publications provided

Responsible Party:	HAL Allergy
ClinicalTrials.gov Identifier:	NCT00932607 History of Changes
Other Study ID Numbers:	SB/0027
Study First Received:	July 2, 2009
Last Updated:	February 6, 2012
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by HAL Allergy:

seasonal
rhinitis
rhinoconjunctivitis

birch pollen
immunotherapy
sublingual

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases

Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013