SUBLIVAC FIX Birch Phase III Short-term Efficacy

NCT ID: NCT02231307

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-11-30

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.

Conditions

Birch Pollen Induced Rhinitis/Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SUBLIVAC FIX Birch 0 AUN/ml

Group Type: PLACEBO_COMPARATOR

SUBLIVAC FIX Birch

Intervention Type: DRUG

SUBLIVAC FIX Birch 40,000 AUN/ml

Group Type: EXPERIMENTAL

SUBLIVAC FIX Birch

Intervention Type: DRUG

Interventions

SUBLIVAC FIX Birch

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HAL Allergy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Pfaar, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany

Locations

Cliniques universitaire St. Luc

Brussels, , Belgium

University Hospital

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

CHR Citadelle

Liège, , Belgium

CHU de Liege

Liège, , Belgium

AKI spol. s.r.o.

Brno, , Czechia

Alergologicka ambulance

Břeclav, , Czechia

Alergologicka ambulance

Liberec, , Czechia

Ordinace Alergologie

Most, , Czechia

Respiral s.r.o.

Pilsen, , Czechia

Ustav imunologie a alergologie

Pilsen, , Czechia

Kasmed s.r.o.

Tábor, , Czechia

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, , Germany

Praxis Dr. Jager

Schwabach, , Germany

Klinik fur Dermatologie & Allergologie

Stuttgart, , Germany

HNO Wiesbaden Institute for Allergology and Rhinology

Wiesbaden, , Germany

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

Bieńkówka, , 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

Tarnów, , Poland

EMC Intytut Medyczny S.A. Przychodnia przy Lowieckiej

Wroclaw, , Poland

ALIAN s.r.o. Ambulancia alergologie a klinickej imunologie

Bardejov, , Slovakia

Alerso s.r.o. Imunoalergologicka ambulancie

Košice, , Slovakia

STALERG s.r.o. Imunoalergologicka ambulancia

Košice, , Slovakia

DANIMED, spol. s.r.o. Ambulancia klinkckej imunologie a alergologie

Levice, , Slovakia

EMED s.r.o. Alergoimunologicke centrum

Prešov, , Slovakia

Countries

Belgium; Czechia; Germany; Poland; Slovakia

References

Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.

Reference Type: DERIVED

PMID: 32926419 (View on PubMed)

Pfaar O, Bachert C, Kuna P, Panzner P, Dzupinova M, Klimek L, van Nimwegen MJ, Boot JD, Yu D, Opstelten DJE, de Kam PJ. Sublingual allergen immunotherapy with a liquid birch pollen product in patients with seasonal allergic rhinoconjunctivitis with or without asthma. J Allergy Clin Immunol. 2019 Mar;143(3):970-977. doi: 10.1016/j.jaci.2018.11.018. Epub 2018 Nov 30.

Reference Type: DERIVED

PMID: 30508538 (View on PubMed)

Other Identifiers

SB/0042

Identifier Type: -

Identifier Source: org_study_id