SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

May 28, 2013 updated by: HAL Allergy

A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Birch in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 639 00
        • AKI, spol s. r.o.
      • Most, Czech Republic, 434 01
        • Ordinace Alergologie
      • Plzeň, Czech Republic, 301 00
        • Respiral s. r.o.
      • Plzeň, Czech Republic, 304 60
        • Ustav imunologie a alergologie
      • Tábor, Czech Republic, 390 01
        • Kasmed s. r.o.
  • Germany
      • Dresden, Germany, 01062
        • Medizinische Fakultät. Klinik und Poliklinik für HNO-Klinik
      • Wiesbaden, Germany, 65183
        • HNO-Wiesbaden - Center for Rhinology and Allergology
    • Sachsen
      • Leipzig, Sachsen, Germany, 04275
        • Praxis fur Atemwegserkrankungen
  • Poland
      • Białystok, Poland, 15-430
        • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
      • Cieszyn, Poland, 43-400
        • NZOS "Zdrowie"
      • Katowice, Poland, 40-952
        • Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach
      • Kraków, Poland, 31-023
        • Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"
      • Lodz, Poland, 90-153
        • Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny Nr.1 im. Norberta Barlickiego w Łodzi
      • Lublin, Poland, 20-089
        • ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna
      • Lublin, Poland, 20-522
        • Nzoz Centrum Alergologii
      • Poznań, Poland, 60-214
        • Centrum Alergologii Teresa Hofman
      • Tarnów, Poland, 33-100
        • ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
      • Wrocław, Poland, 50-220
        • EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej
      • Wrocław, Poland, 50-434
        • NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
      • Łódź, Poland, 90-553
        • Nzoz Centrum Alergologii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Age ≥ 18 ≤ 60 years
  • Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma
  • FEV1 > 70% for patients with a history of asthma, FEV > 70% or PEF > 80% for patients without a history of asthma

  • A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen assessed within

    1 year before randomization.

  • Positive serum specific anti-birch IgE-test (> 0.7 U/mL)

  • A positive TNPT for birch pollen at screening (Lebel score ≥ 6) at

    • 10,000 AU/mL

Exclusion Criteria:

  • Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3mm) to allergens other than birch pollen
  • Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets
  • Completed immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
  • Completed unsuccessful specific immunotherapy in the past
  • Vaccination within one week before start of therapy or during the initiation phase
  • Anti-IgE therapy within the 6 months prior to inclusion and during the study
  • Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
  • Active malignancies or any malignant disease during the previous 5 years
  • Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders
  • Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study
  • Moderate to severe nasal obstructive diseases that preclude a TNPT (septal deviation, nasal polyps, recent nasal surgery, etc.)
  • Diseases with a contraindication for the use of Adrenaline (e.g. hyperthyroidism, glaucoma)
  • Use of systemic steroids within 4 weeks before start of the study and during the study
  • Treatment with systemic and local β-blockers
  • Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
  • Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or -pill)
  • Alcohol, drug or medication abuse within the past year
  • Any clinically significant abnormal laboratory parameter at screening
  • Lack of cooperation or compliance
  • Severe psychiatric, psychological, or neurological disorders
  • Patients who are employees of the institution or 1st grade relatives or partners of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: SUBLIVAC FIX Birch 0 AUN/ml
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo
Active Comparator: SUBLIVAC FIX Birch 3,333 AUN/ml
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo
Active Comparator: SUBLIVAC FIX Birch 10,000 AUN/ml
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo
Active Comparator: SUBLIVAC FIX Birch 20,000 AUN/ml
Evaluation of the SUBLIVAC FIX Birch 20,000 AUN/ml by an independent safety committee
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo
Active Comparator: SUBLIVAC FIX Birch 40,000 AUN/ml
Start of SUBLIVAC FIX Birch 40,000 AUN/ml arm depends on safety in the SUBLIVAC FIX Birch 20,000 AUN/ml arm evaluated by an independent safety committee
Drug: SUBLIVAC FIX Birch
Comparison of different dosages to placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nasal Provocation Test (NPT)
Time Frame: 5 months
5 months
Number of related AEs
Time Frame: First ten days of study medication intake
First ten days of study medication intake

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum specific immunoglobulin levels (IgE, IgG, IgG4)
Time Frame: 5 months
5 months
Number of local and systemic reactions
Time Frame: Duration of study medication intake (approximately 5 months)
Duration of study medication intake (approximately 5 months)
Peak Nasal Inspiratory Flow (PNIF)
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HAL Allergy

Investigators

  • Study Chair: Oliver Pfaar, PD. Dr. med., Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 3, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 13, 2012

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB/0038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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