SUBLIVAC FIX Birch Phase III Short-term Efficacy

September 22, 2016 updated by: HAL Allergy

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Clinical Efficacy and Safety of SUBLIVAC FIX Birch Immunotherapy in Patients Suffering From Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen.

The aim of this phase III study is to asses if SUBLIVAC FIX Birch is safe and effective in reducing birch allergy induced symptoms and birch allergy medication usage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

406

Phase

  • Phase 3

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

  • Belgium
      • Brussels, Belgium
        • Cliniques universitaire St. Luc
      • Gent, Belgium
        • University Hospital
      • Leuven, Belgium
        • UZ Leuven
      • Liege, Belgium
        • CHR Citadelle
      • Liege, Belgium
        • CHU de Liège
  • Czech Republic
      • Breclav, Czech Republic
        • Alergologicka ambulance
      • Brno, Czech Republic
        • AKI spol. s.r.o.
      • Liberec, Czech Republic
        • Alergologicka ambulance
      • Most, Czech Republic
        • Ordinace Alergologie
      • Plzen, Czech Republic
        • Respiral s.r.o.
      • Plzen, Czech Republic
        • Ustav imunologie a alergologie
      • Tabor, Czech Republic
        • KASMED s.r.o.
  • Germany
      • Bamberg, Germany
        • CIMS Studienzentrum Bamberg
      • Berlin, Germany
        • Charité Universitätsmedizin
      • Hamburg, Germany
        • Dermatologikum Hamburg
      • Heidelberg, Germany
        • HNO Gemeinschaftspraxis
      • Hildesheim, Germany
        • Hautarztpraxis fur Dermatologie & asthetische medizin
      • Leipzig, Germany
        • Praxis fur Atemwegserkrankungen
      • Saalfeld/Saale, Germany
        • FA HNOW Allergologie
      • Schwabach, Germany
        • Praxis Dr. Jager
      • Stuttgart, Germany
        • Klinik fur Dermatologie & Allergologie
      • Wiesbaden, Germany
        • HNO Wiesbaden Institute for Allergology and Rhinology
  • Poland
      • Bialystok, Poland
        • Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
      • Bielsko-Biala, Poland
        • NZOZ ZLS Medex Sp. z o.o. Poradnia Alergologiczna
      • Bienkowka, Poland
        • SP-ZOZ Osrodek Zdrowia w Bienkowce
      • Gdansk, Poland
        • Nzoz Clinica Vitae
      • Krakow, Poland
        • Grazyna Pulka Specjalistyczny Osrodek 'All-Med'
      • Lodz, Poland
        • NZOZ Centrum Alergologii Krzysztof Buczylko
      • Lodz, Poland
        • Poradnia Alergologii i Chorob Pluc Uniwersytecki Szpital Kliniczny
      • Lublin, Poland
        • NZOZ Centrum Alergologii
      • Lublin, Poland
        • Przychodnia Alergologiczno-Pulmonologiczna ALERGOPNEUMA
      • Poznan, Poland
        • Centrum Alergologii Teresa Hofman
      • Strzelce Opolskie, Poland
        • Centrumk Medyczne Lucyna i Andrzej Dymek
      • Tarnow, Poland
        • ALERGOMED Specjalistyczna Przychodnia Lekarska
      • Wroclaw, Poland
        • EMC Intytut Medyczny S.A. Przychodnia przy Lowieckiej
  • Slovakia
      • Bardejov, Slovakia
        • ALIAN s.r.o. Ambulancia alergologie a klinickej imunologie
      • Kosice, Slovakia
        • Alerso s.r.o. Imunoalergologicka ambulancie
      • Kosice, Slovakia
        • STALERG s.r.o. Imunoalergologicka ambulancia
      • Levice, Slovakia
        • DANIMED, spol. s.r.o. Ambulancia klinkckej imunologie a alergologie
      • Presov, Slovakia
        • EMED s.r.o. Alergoimunologicke centrum

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Age ≥ 18 and ≤65 years
  • Moderate-to-severe birch pollen induced allergic rhinitis/rhinoconjunctivitis based on ARIA classification for at least 2 consecutive years
  • FEV1 (forced expiratory volume at one second) > 70% (of predicted value) for patients with a history of asthma, FEV1 > 70% or PEF (peak expiratory flow) > 80% (of predicted value) for patients without a history of asthma
  • Positive SPT (skin prick test) for birch pollen (mean wheal diameter ≥ 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3mm)) assessed during screening.
  • Serum specific anti-birch IgE (immunoglobulin E) concentration >0.7 U/ml
  • Patients should be willing and capable to complete an e-diary daily during the birch pollen season (≥ 60% compliance in completion between Visit 1 and 2).
  • A positive Nasal Provocation Test to birch pollen at Visit 2 (Lebel score ≥ 6) or a documented positive test within 1 year before start of treatment

Exclusion Criteria:

  • Patients sensitized and symptomatic to pets should not be included if they are regularly exposed to pets
  • Specific immunotherapy (SCIT or SLIT) with birch pollen or a cross-reacting allergen within the last 5 years
  • SPT positive (mean wheal diameter ≥ 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter ≥ 3mm)) patients to allergen(s) other than birch pollen, in the absence of a negative provocation test for this allergen(s) (within 1 year), who are expected to have clinically relevant symptoms during the birch pollen season
  • Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years
  • (Ongoing) allergen-specific immunotherapy (SCIT or SLIT) with any allergen(s) during the study period
  • Vaccination one week before start of treatment and/or during the up-dosing phase
  • Treatment with experimental products within the last 3 months or biologicals (including anti-IgE or TNF (tumor necrosis factor) - α treatment) within the last 6 months or during the study
  • Uncontrolled asthma or other active respiratory diseases
  • Clinically significant chronic sinusitis, ocular infection or severe inflammation of the oral mucosa
  • Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
  • Active malignancies or any malignant disease in the last 5 years
  • Acute or chronic disease that in the opinion of the investigator is an additional risk for the patients, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders
  • Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
  • Use of systemic corticosteroids 4 weeks before the study
  • Treatment with systemic or local β-blockers
  • Known hypersensitivity to any of the excipients (Disodium phosphate dihydrate, Sodium dihydrogen phosphate dehydrate, aminocaproic acid, Peppermint oil, Caramel Colorant or Glycerol)
  • A positive urine pregnancy test, lactation or inadequate contraceptive methods (adequate methods: oral contraceptives, IUD (intrauterine device), condom use and having no sexual relationship with a man)
  • Alcohol-, drug or medication abuse
  • Lack of co-operation or compliance
  • Severe psychiatric, psychological, or neurological disorders
  • Any physical or mental condition that precludes administration or allergen-specific immunotherapy, compliance or participation in a clinical trial
  • Patients who are employees of the department, 1st grade relatives, or partners of the investigator
  • Patients who have planned holidays outside the country for more than 7 continuous days during the defined pollen season (1st of March till 31st of May)

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
Experimental: SUBLIVAC FIX Birch 40,000 AUN/ml
Drug: SUBLIVAC FIX Birch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
combined symptom medication score
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
symptom score
Time Frame: 3 months
3 months
Quality of Life questionnaires
Time Frame: 3 months
3 months
Serum specific immunoglobulin levels
Time Frame: up to 9 months
up to 9 months
local and systemic reactions
Time Frame: up to 9 months
up to 9 months
(serious) adverse events
Time Frame: up to 9 months
up to 9 months
blood safety parameters
Time Frame: up to 9 months
up to 9 months
urinalysis
Time Frame: up to 9 months
up to 9 months
medication score
Time Frame: up to 3 months
up to 3 months

Collaborators and Investigators

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

Sponsor

HAL Allergy

Investigators

  • Principal Investigator: Oliver Pfaar, Prof. Dr., 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

September 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

September 1, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB/0042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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