NCT02231307

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_3

Geographic Reach
5 countries

40 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

August 25, 2014

Last Update Submit

September 22, 2016

Conditions

Birch Pollen Induced Rhinitis/Rhinoconjunctivitis

Keywords

sublingual immunotherapybirch pollenallergic rhinitis / rhinoconjunctivitisefficacy

Outcome Measures

Primary Outcomes (1)

  • combined symptom medication score

    3 months

Secondary Outcomes (8)

  • symptom score

    3 months

  • Quality of Life questionnaires

    3 months

  • Serum specific immunoglobulin levels

    up to 9 months

  • local and systemic reactions

    up to 9 months

  • (serious) adverse events

    up to 9 months

  • +3 more secondary outcomes

Study Arms (2)

SUBLIVAC FIX Birch 0 AUN/ml

PLACEBO COMPARATOR
Drug: SUBLIVAC FIX Birch

SUBLIVAC FIX Birch 40,000 AUN/ml

EXPERIMENTAL
Drug: SUBLIVAC FIX Birch

Interventions

SUBLIVAC FIX BirchDRUG
SUBLIVAC FIX Birch 0 AUN/mlSUBLIVAC FIX Birch 40,000 AUN/ml

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Cliniques universitaire St. Luc

Brussels, Belgium

Location

University Hospital

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHR Citadelle

Liège, Belgium

Location

CHU de Liege

Liège, Belgium

Location

AKI spol. s.r.o.

Brno, Czechia

Location

Alergologicka ambulance

Břeclav, Czechia

Location

Alergologicka ambulance

Liberec, Czechia

Location

Ordinace Alergologie

Most, Czechia

Location

Respiral s.r.o.

Pilsen, Czechia

Location

Ustav imunologie a alergologie

Pilsen, Czechia

Location

Kasmed s.r.o.

Tábor, Czechia

Location

CIMS Studienzentrum Bamberg

Bamberg, Germany

Location

Charite Universitatsmedizin

Berlin, Germany

Location

Dermatologikum Hamburg

Hamburg, Germany

Location

HNO Gemeinschaftspraxis

Heidelberg, Germany

Location

Hautarztpraxis fur Dermatologie & asthetische medizin

Hildesheim, Germany

Location

Praxis fur Atemwegserkrankungen

Leipzig, Germany

Location

FA HNOW Allergologie

Saalfeld, Germany

Location

Praxis Dr. Jager

Schwabach, Germany

Location

Klinik fur Dermatologie & Allergologie

Stuttgart, Germany

Location

HNO Wiesbaden Institute for Allergology and Rhinology

Wiesbaden, Germany

Location

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

Bialystok, Poland

Location

NZOZ ZLS Medex Sp. z o.o. Poradnia Alergologiczna

Bielsko-Biala, Poland

Location

SP-ZOZ Osrodek Zdrowia w Bienkowce

Bieńkówka, Poland

Location

NZOZ Clinica Vitae

Gdansk, Poland

Location

Grazyna Pulka Specjalistyczny Osrodek 'All-Med'

Krakow, Poland

Location

NZOZ Centrum Alergologii Krzysztof Buczylko

Lodz, Poland

Location

Poradnia Alergologii i Chorob Pluc Uniwersytecki Szpital Kliniczny

Lodz, Poland

Location

NZOZ Centrum Alergologii

Lublin, Poland

Location

Przychodnia Alergologiczno-Pulmonologiczna ALERGOPNEUMA

Lublin, Poland

Location

Centrum Alergologii Teresa Hofman

Poznan, Poland

Location

Centrumk Medyczne Lucyna i Andrzej Dymek

Strzelce Opolskie, Poland

Location

ALERGOMED Specjalistyczna Przychodnia Lekarska

Tarnów, Poland

Location

EMC Intytut Medyczny S.A. Przychodnia przy Lowieckiej

Wroclaw, Poland

Location

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

Bardejov, Slovakia

Location

Alerso s.r.o. Imunoalergologicka ambulancie

Košice, Slovakia

Location

STALERG s.r.o. Imunoalergologicka ambulancia

Košice, Slovakia

Location

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

Levice, Slovakia

Location

EMED s.r.o. Alergoimunologicke centrum

Prešov, Slovakia

Location

Related Publications (2)

  • 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.

    PMID: 32926419DERIVED

  • 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.

    PMID: 30508538DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Oliver Pfaar, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

September 4, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2015

Study Completion

November 1, 2015

Last Updated

September 23, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(5)DE(10)CZ(7)PL(13)SL(5)