Birch Pollen Induced Rhinitis/RhinoconjunctivitisPhase 3NCT02231307

SUBLIVAC FIX Birch Phase III Short-term Efficacy

A Phase 3 study testing SUBLIVAC FIX Birch in people with Birch Pollen Induced Rhinitis/Rhinoconjunctivitis, run by HAL Allergy at 40 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Birch Pollen Induced Rhinitis/Rhinoconjunctivitis
What is being tested?: SUBLIVAC FIX Birch
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 406 participants
Where: 40 sitesin 5 countries
Study dates: Sep 2014to Nov 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 23Show fewer

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)

Trial locations and contacts

40 sites in 5 countries.

Country

City, postcode or hospital

40 sites in 5 countries

Poland13 sites

Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Bialystok
NZOZ ZLS Medex Sp. z o.o. Poradnia Alergologiczna
Bielsko-Biala
SP-ZOZ Osrodek Zdrowia w Bienkowce
Bieńkówka
NZOZ Clinica Vitae
Gdansk
Grazyna Pulka Specjalistyczny Osrodek 'All-Med'
Krakow
NZOZ Centrum Alergologii Krzysztof Buczylko
Lodz
Poradnia Alergologii i Chorob Pluc Uniwersytecki Szpital Kliniczny
Lodz
NZOZ Centrum Alergologii
Lublin
Przychodnia Alergologiczno-Pulmonologiczna ALERGOPNEUMA
Lublin
Centrum Alergologii Teresa Hofman
Poznan
Centrumk Medyczne Lucyna i Andrzej Dymek
Strzelce Opolskie
ALERGOMED Specjalistyczna Przychodnia Lekarska
Tarnów
EMC Intytut Medyczny S.A. Przychodnia przy Lowieckiej
Wroclaw

Other trials in Poland

Germany10 sites

CIMS Studienzentrum Bamberg
Bamberg
Charite Universitatsmedizin
Berlin
Dermatologikum Hamburg
Hamburg
HNO Gemeinschaftspraxis
Heidelberg
Hautarztpraxis fur Dermatologie & asthetische medizin
Hildesheim
Praxis fur Atemwegserkrankungen
Leipzig
FA HNOW Allergologie
Saalfeld
Praxis Dr. Jager
Schwabach
Klinik fur Dermatologie & Allergologie
Stuttgart
HNO Wiesbaden Institute for Allergology and Rhinology
Wiesbaden

Other trials in Germany

Czechia7 sites

Alergologicka ambulance
Břeclav
AKI spol. s.r.o.
Brno
Alergologicka ambulance
Liberec
Ordinace Alergologie
Most
Respiral s.r.o.
Pilsen
Ustav imunologie a alergologie
Pilsen
Kasmed s.r.o.
Tábor

Other trials in Czechia

Belgium5 sites

Cliniques universitaire St. Luc
Brussels
University Hospital
Ghent
UZ Leuven
Leuven
CHR Citadelle
Liège
CHU de Liege
Liège

Other trials in Belgium

Slovakia5 sites

ALIAN s.r.o. Ambulancia alergologie a klinickej imunologie
Bardejov
Alerso s.r.o. Imunoalergologicka ambulancie
Košice
STALERG s.r.o. Imunoalergologicka ambulancia
Košice
DANIMED, spol. s.r.o. Ambulancia klinkckej imunologie a alergologie
Levice
EMED s.r.o. Alergoimunologicke centrum
Prešov

Other trials in Slovakia

About this study

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.

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
Being tested: SUBLIVAC FIX Birch
Keywords: sublingual immunotherapy, birch pollen, allergic rhinitis / rhinoconjunctivitis, efficacy
Medical subject headings: Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SUBLIVAC FIX BirchDrug

Study groups in NCT02231307
Study group	Role	What they receive
SUBLIVAC FIX Birch 0 AUN/ml	Placebo comparator	Not described Receives: Drug: SUBLIVAC FIX Birch
SUBLIVAC FIX Birch 40,000 AUN/ml	Experimental	Not described Receives: Drug: SUBLIVAC FIX Birch

What is being measured

The primary outcome is the main question the study is designed to answer.

combined symptom medication score
Measured: 3 months

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Nov 2015

First posted4 Sep 2014 (estimated)
Study startSep 2014
Primary completionJul 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Birch Pollen Induced Rhinitis/RhinoconjunctivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 406 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02231307
Sponsor's protocol ID: SB/0042
Status last verified: Sep 2016
First submitted: 25 Aug 2014
Last updated: 23 Sep 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 32926419
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.
PubMed 30508538

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02231307
Acronym / sponsor ID: SB/0042
Conditions: Birch Pollen Induced Rhinitis/Rhinoconjunctivitis
Keywords: sublingual immunotherapy, birch pollen, allergic rhinitis / rhinoconjunctivitis, efficacy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 406 participants (actual)
Lead sponsor: HAL AllergyIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Jul 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 4 Sep 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SUBLIVAC FIX Birch 0 AUN/ml	Placebo comparator	Drug: SUBLIVAC FIX Birch
SUBLIVAC FIX Birch 40,000 AUN/ml	Experimental	Drug: SUBLIVAC FIX Birch

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SUBLIVAC FIX Birch	Drug	SUBLIVAC FIX Birch 0 AUN/ml, SUBLIVAC FIX Birch 40,000 AUN/ml

Primary outcome

combined symptom medication score
Time frame: 3 months

8 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
Derived from this study: PubMed 32926419Fortescue 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.
Derived from this study: PubMed 30508538Pfaar 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oliver Pfaar, Prof. Dr. principal investigator

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

40 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SUBLIVAC FIX Birch in people with Birch Pollen Induced Rhinitis/Rhinoconjunctivitis, run by HAL Allergy at 40 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Poland, Germany, Czechia, Belgium, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

combined symptom medication score (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231307, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.