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SUBLIVAC FIX Birch Phase III Short-term Efficacy

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ClinicalTrials.gov Identifier: NCT02231307
Recruitment Status : Completed
First Posted : September 4, 2014
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
HAL Allergy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Birch Pollen Induced Rhinitis/Rhinoconjunctivitis Drug: SUBLIVAC FIX Birch Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : September 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : November 2015

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



Primary Outcome Measures :
  1. combined symptom medication score [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. symptom score [ Time Frame: 3 months ]
  2. Quality of Life questionnaires [ Time Frame: 3 months ]
  3. Serum specific immunoglobulin levels [ Time Frame: up to 9 months ]
  4. local and systemic reactions [ Time Frame: up to 9 months ]
  5. (serious) adverse events [ Time Frame: up to 9 months ]
  6. blood safety parameters [ Time Frame: up to 9 months ]
  7. urinalysis [ Time Frame: up to 9 months ]
  8. medication score [ Time Frame: up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231307


Locations
Belgium
Cliniques universitaire St. Luc
Brussels, Belgium
University Hospital
Gent, Belgium
UZ Leuven
Leuven, Belgium
CHR Citadelle
Liege, Belgium
CHU de Liege
Liege, Belgium
Czech Republic
Alergologicka ambulance
Breclav, Czech Republic
AKI spol. s.r.o.
Brno, Czech Republic
Alergologicka ambulance
Liberec, Czech Republic
Ordinace Alergologie
Most, Czech Republic
Respiral s.r.o.
Plzen, Czech Republic
Ustav imunologie a alergologie
Plzen, Czech Republic
Kasmed s.r.o.
Tabor, Czech Republic
Germany
CIMS Studienzentrum Bamberg
Bamberg, Germany
Charite Universitatsmedizin
Berlin, Germany
Dermatologikum Hamburg
Hamburg, Germany
HNO Gemeinschaftspraxis
Heidelberg, Germany
Hautarztpraxis fur Dermatologie & asthetische medizin
Hildesheim, Germany
Praxis fur Atemwegserkrankungen
Leipzig, Germany
FA HNOW Allergologie
Saalfeld/Saale, Germany
Praxis Dr. Jager
Schwabach, Germany
Klinik fur Dermatologie & Allergologie
Stuttgart, Germany
HNO Wiesbaden Institute for Allergology and Rhinology
Wiesbaden, Germany
Poland
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Bialystok, Poland
NZOZ ZLS Medex Sp. z o.o. Poradnia Alergologiczna
Bielsko-Biala, Poland
SP-ZOZ Osrodek Zdrowia w Bienkowce
Bienkowka, Poland
NZOZ Clinica Vitae
Gdansk, Poland
Grazyna Pulka Specjalistyczny Osrodek 'All-Med'
Krakow, Poland
NZOZ Centrum Alergologii Krzysztof Buczylko
Lodz, Poland
Poradnia Alergologii i Chorob Pluc Uniwersytecki Szpital Kliniczny
Lodz, Poland
NZOZ Centrum Alergologii
Lublin, Poland
Przychodnia Alergologiczno-Pulmonologiczna ALERGOPNEUMA
Lublin, Poland
Centrum Alergologii Teresa Hofman
Poznan, Poland
Centrumk Medyczne Lucyna i Andrzej Dymek
Strzelce Opolskie, Poland
ALERGOMED Specjalistyczna Przychodnia Lekarska
Tarnow, Poland
EMC Intytut Medyczny S.A. Przychodnia przy Lowieckiej
Wroclaw, Poland
Slovakia
ALIAN s.r.o. Ambulancia alergologie a klinickej imunologie
Bardejov, Slovakia
Alerso s.r.o. Imunoalergologicka ambulancie
Kosice, Slovakia
STALERG s.r.o. Imunoalergologicka ambulancia
Kosice, Slovakia
DANIMED, spol. s.r.o. Ambulancia klinkckej imunologie a alergologie
Levice, Slovakia
EMED s.r.o. Alergoimunologicke centrum
Presov, Slovakia
Sponsors and Collaborators
HAL Allergy
Investigators
Principal Investigator: Oliver Pfaar, Prof. Dr. Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany

Responsible Party: HAL Allergy
ClinicalTrials.gov Identifier: NCT02231307     History of Changes
Other Study ID Numbers: SB/0042
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by HAL Allergy:
sublingual immunotherapy
birch pollen
allergic rhinitis / rhinoconjunctivitis
efficacy

Additional relevant MeSH terms:
Rhinitis
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases