Allergic RhinitisPhase 2NCT01639768
SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding
A Phase 2 study testing SUBLIVAC FIX Birch in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 20 sites in 3 countries.
Trial summary
The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- SUBLIVAC FIX Birch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 20 sitesin 3 countries
- Study dates
- Jul 2012to Apr 2013
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Age ≥ 18 ≤ 60 years
- Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma
- FEV1 > 70% for patients with a history of asthma, FEV > 70% or PEF > 80% for patients without a history of asthma
- A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen assessed within
- 1 year before randomization.
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- Positive serum specific anti-birch IgE-test (> 0.7 U/mL)
- A positive TNPT for birch pollen at screening (Lebel score ≥ 6) at
- 10,000 AU/mL
Who cannot join
- Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3mm) to allergens other than birch pollen
- Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets
- Completed immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
- Completed unsuccessful specific immunotherapy in the past
- Vaccination within one week before start of therapy or during the initiation phase
- Anti-IgE therapy within the 6 months prior to inclusion and during the study
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- Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
- Active malignancies or any malignant disease during the previous 5 years
- Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders
- Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study
- Moderate to severe nasal obstructive diseases that preclude a TNPT (septal deviation, nasal polyps, recent nasal surgery, etc.)
- Diseases with a contraindication for the use of Adrenaline (e.g. hyperthyroidism, glaucoma)
- Use of systemic steroids within 4 weeks before start of the study and during the study
- Treatment with systemic and local β-blockers
- Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study
- Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or -pill)
- Alcohol, drug or medication abuse within the past year
- Any clinically significant abnormal laboratory parameter at screening
- Lack of cooperation or compliance
- Severe psychiatric, psychological, or neurological disorders
- Patients who are employees of the institution or 1st grade relatives or partners of the investigator
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
Poland12 sites
Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny
Bialystok, 15-430
NZOS "Zdrowie"
Cieszyn, 43-400
Poradnia Alergologiczna Samodzielnego Publicznego Szpitala Nr 5 Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-952
Specjalistyczny Ośrodek Alergologiczno-Internistyczny "ALL-MED"
Krakow, 31-023
Poradnia Alergologii i Chorób Płuc SP ZOZ Uniwersytecki Szpital Kliniczny Nr.1 im. Norberta Barlickiego w Łodzi
Lodz, 90-153
NZOZ Centrum Alergologii
Lodz, 90-553
ALERGOPNEUMA Marek Michnar i Wspolnicy Sp. Jawna
Lublin, 20-089
NZOZ Centrum Alergologii
Lublin, 20-522
Centrum Alergologii Teresa Hofman
Poznan, 60-214
ALERGOMED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnów, 33-100
EMC Intytut Medyczny S.A. Przychodnia przy Łowieckiej
Wroclaw, 50-220
NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy
Wroclaw, 50-434
Czechia5 sites
AKI, spol s. r.o.
Brno, 639 00
Ordinace Alergologie
Most, 434 01
Respiral s. r.o.
Pilsen, 301 00
Ústav imunologie a alergologie
Pilsen, 304 60
Kasmed s. r.o.
Tábor, 390 01
Germany3 sites
Medizinische Fakultät. Klinik und Poliklinik für HNO-Klinik
Dresden, 01062
Praxis für Atemwegserkrankungen
Leipzig, Saxony, 04275
HNO-Wiesbaden - Center for Rhinology and Allergology
Wiesbaden, 65183
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Birch in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen
The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch compared to placebo.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- SUBLIVAC FIX Birch
- Keywords
- Sublingual immunotherapy, Dose range finding, Dose tolerability, Birch pollen, Allergic rhinitis/rhinoconjunctivitis, Safety, Immunogenicity
- 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
Comparison of different dosages to placebo
| Study group | Role | What they receive |
|---|---|---|
| SUBLIVAC FIX Birch 0 AUN/ml | Placebo comparator | Not described Receives: Drug: SUBLIVAC FIX Birch |
| SUBLIVAC FIX Birch 3,333 AUN/ml | Active comparator | Not described Receives: Drug: SUBLIVAC FIX Birch |
| SUBLIVAC FIX Birch 10,000 AUN/ml | Active comparator | Not described Receives: Drug: SUBLIVAC FIX Birch |
| SUBLIVAC FIX Birch 20,000 AUN/ml | Active comparator | Evaluation of the SUBLIVAC FIX Birch 20,000 AUN/ml by an independent safety committee Receives: Drug: SUBLIVAC FIX Birch |
| SUBLIVAC FIX Birch 40,000 AUN/ml | Active comparator | Start of SUBLIVAC FIX Birch 40,000 AUN/ml arm depends on safety in the SUBLIVAC FIX Birch 20,000 AUN/ml arm evaluated by an independent safety committee Receives: Drug: SUBLIVAC FIX Birch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Provocation Test (NPT)
Measured: 5 months
Number of related AEs
Measured: First ten days of study medication intake
Secondary outcomes (3)
Serum specific immunoglobulin levels (IgE, IgG, IgG4)
Measured: 5 months
Number of local and systemic reactions
Measured: Duration of study medication intake (approximately 5 months)
Peak Nasal Inspiratory Flow (PNIF)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Pfaar, PD. Dr. med., Study chair, Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639768
- Sponsor's protocol ID
- SB/0038
- Status last verified
- May 2013
- First submitted
- 3 Jul 2012
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pfaar O, van Twuijver E, Boot JD, Opstelten DJ, Klimek L, van Ree R, Diamant Z, Kuna P, Panzner P. A randomized DBPC trial to determine the optimal effective and safe dose of a SLIT-birch pollen extract for the treatment of allergic rhinitis: results of a phase II study. Allergy. 2016 Jan;71(1):99-107. doi: 10.1111/all.12760. Epub 2015 Oct 26.
PubMed 26417901
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Birch in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen
- ClinicalTrials.gov ID
- NCT01639768
- Acronym / sponsor ID
- SB/0038
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- Sublingual immunotherapy, Dose range finding, Dose tolerability, Birch pollen, Allergic rhinitis/rhinoconjunctivitis, Safety, Immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Jul 2012 (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 the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SUBLIVAC FIX Birch 0 AUN/ml | Placebo comparator | Drug: SUBLIVAC FIX Birch |
| SUBLIVAC FIX Birch 3,333 AUN/ml | Active comparator | Drug: SUBLIVAC FIX Birch |
| SUBLIVAC FIX Birch 10,000 AUN/ml | Active comparator | Drug: SUBLIVAC FIX Birch |
| SUBLIVAC FIX Birch 20,000 AUN/ml | Active comparator | Drug: SUBLIVAC FIX BirchEvaluation of the SUBLIVAC FIX Birch 20,000 AUN/ml by an independent safety committee |
| SUBLIVAC FIX Birch 40,000 AUN/ml | Active comparator | Drug: SUBLIVAC FIX BirchStart of SUBLIVAC FIX Birch 40,000 AUN/ml arm depends on safety in the SUBLIVAC FIX Birch 20,000 AUN/ml arm evaluated by an independent safety committee |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Signed informed consent
- Age ≥ 18 ≤ 60 years
- Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma
- FEV1 > 70% for patients with a history of asthma, FEV > 70% or PEF > 80% for patients without a history of asthma
- A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen assessed within
Key exclusion criteria (21 listed)
- Patients with (expected) clinically relevant symptoms during the course of the trial due to concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3mm) to allergens other than birch pollen
- Patients sensitized to pets should not be included if they are regularly exposed to pets and are symptomatic upon exposure to pets
- Completed immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
- Completed unsuccessful specific immunotherapy in the past
- Vaccination within one week before start of therapy or during the initiation phase
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 BirchComparison of different dosages to placebo | Drug | SUBLIVAC FIX Birch 0 AUN/ml, SUBLIVAC FIX Birch 10,000 AUN/ml, SUBLIVAC FIX Birch 20,000 AUN/ml, SUBLIVAC FIX Birch 3,333 AUN/ml, SUBLIVAC FIX Birch 40,000 AUN/ml |
Primary outcome
Nasal Provocation Test (NPT)
Time frame: 5 months
Number of related AEs
Time frame: First ten days of study medication intake
3 secondary outcomes
Serum specific immunoglobulin levels (IgE, IgG, IgG4)
Time frame: 5 months
Number of local and systemic reactions
Time frame: Duration of study medication intake (approximately 5 months)
Peak Nasal Inspiratory Flow (PNIF)
Time frame: 5 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 29 May 2013.
- Derived from this study: PubMed 26417901Pfaar O, van Twuijver E, Boot JD, Opstelten DJ, Klimek L, van Ree R, Diamant Z, Kuna P, Panzner P. A randomized DBPC trial to determine the optimal effective and safe dose of a SLIT-birch pollen extract for the treatment of allergic rhinitis: results of a phase II study. Allergy. 2016 Jan;71(1):99-107. doi: 10.1111/all.12760. Epub 2015 Oct 26.
Related trials for Allergic Rhinitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
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, PD. Dr. med. study chair
Zentrum für Rhinologie und Allergologie, An-den-Quellen-10, 65189 Wiesbaden, Germany
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUBLIVAC FIX Birch in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 20 sites in 3 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 9 inclusion and 21 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Poland, Czechia, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Nasal Provocation Test (NPT) (time frame: 5 months). The study lists 2 primary outcomes in all. 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 NCT01639768, which also lists 1 linked publication.
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 29 May 2013.