Allergic RhinitisPhase 4NCT01918956
PURETHAL Birch RUSH Study
A Phase 4 study testing PURETHAL Birch, 20.000 AUM/ml in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 8 sites in Poland.
Trial summary
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- PURETHAL Birch, 20.000 AUM/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesPoland
- Study dates
- Sep 2013to Apr 2014
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age ≥12 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 mild to moderate asthma, FEV1>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.
- Positive serum specific anti-birch IgE-test (>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization.
Who cannot join
- Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
- Any specific immunotherapy (SCIT or SLIT) during the study period
- Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
- Active malignancies or any malignant disease within the past 5 years
- Severe uncontrolled diseases that could increase the risk for patients participating in the study
- Acute/active inflammation or infection of the target organs at the start of the study
Show all 19Show fewer
- Secondary changes of the target organ
- Diseases with a contraindication for the use of adrenaline
- Use of systemic steroids within 4 weeks before start of the study and during the study
- Treatment with systemic and local β-blockers
- 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
- 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
- Alcohol, drug or medication abuse within the past year
- Any clinically significant abnormal laboratory parameter at screening
- Lack or expected lack of cooperation or compliance
- Severe psychiatric, psychological, or neurological disorders
- Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Poland8 sites
NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.
Bialystok, 15-183
NZOZ Alergia
Bielsko-Biala, 43-300
NZOZ ClinicaVitae
Gdansk, 80-405
Medica Pro Familia Sp.zo.o S.K.A
Katowice, 40-954
NZOZ Centrum Alergologii
Łódz, 90-553
ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnów, 33-100
Specjalistyczne Centrum Medyczne CenterMed
Tarnów, 33-100
NZOZ CUM PROXIMUM Sp. z o.o.
Wroclaw, 53-428
About this study
Official title: A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Birch Given With a Rush Up-dosing Regimen to Patients With Allergic Rhinitis/Rhinoconjunctivitis
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks).
The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes.
A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- PURETHAL Birch, 20.000 AUM/ml
- Keywords
- immunotherapy, birch pollen, seasonal allergy, up-dosing
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PURETHAL Birch, 20.000 AUM/mlBiological
comparison of different up-dosing regimes
| Study group | Role | What they receive |
|---|---|---|
| conventional regimen of PURETHAL Birch | Active comparator | Initial treatment:
6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml PURETHAL Birch, 20.000 AUM/ml (week 1, 2, 3, 4, 5, 6).
Maintenance treatment:
0.5 ml PURETHAL Birch, 20.000 AUM/ml, in intervals according to registered scheme (week 8, 10, 12). Receives: Biological: PURETHAL Birch, 20.000 AUM/ml |
| rush regimen of PURETHAL Birch | Experimental | Initial treatment:
3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml PURETHAL Birch, 20.000 AUM/ml (week 1, 2, 3)
Maintenance treatment:
0.5 ml PURETHAL Birch, 20.000 AUM/ml, in 2-weekly intervals (week 5, 7, 9). Receives: Biological: PURETHAL Birch, 20.000 AUM/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients successfully reaching the maintenance dose
Measured: 12 weeks
Secondary outcomes (2)
Early and late local and systemic reactions
Measured: 30 minutes after IMP injection and 24 hours after injection
Immunological parameters (IgE, IgG)
Measured: 10 weeks rush regime, 13 weeks conventional regime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ergomed
- Responsible party
- Sponsor
- Investigators
- Piotr Buczyłko, Prof., Principal investigator, NZOZ Centrum Alergologii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918956
- Sponsor's protocol ID
- PB/0040
- Status last verified
- Apr 2014
- First submitted
- 7 Aug 2013
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Birch Given With a Rush Up-dosing Regimen to Patients With Allergic Rhinitis/Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01918956
- Acronym / sponsor ID
- PB/0040
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- immunotherapy, birch pollen, seasonal allergy, up-dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Collaborators
- Ergomed
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Aug 2013 (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.
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks).
The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes.
A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional regimen of PURETHAL Birch | Active comparator | Biological: PURETHAL Birch, 20.000 AUM/mlInitial treatment: 6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml PURETHAL Birch, 20.000 AUM/ml (week 1, 2, 3, 4, 5, 6). Maintenance treatment: 0.5 ml PURETHAL Birch, 20.000 AUM/ml, in intervals according to registered scheme (week 8, 10, 12). |
| rush regimen of PURETHAL Birch | Experimental | Biological: PURETHAL Birch, 20.000 AUM/mlInitial treatment: 3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml PURETHAL Birch, 20.000 AUM/ml (week 1, 2, 3) Maintenance treatment: 0.5 ml PURETHAL Birch, 20.000 AUM/ml, in 2-weekly intervals (week 5, 7, 9). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent.
- Age ≥12 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 mild to moderate asthma, FEV1>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.
Key exclusion criteria (19 listed)
- Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years
- Any specific immunotherapy (SCIT or SLIT) during the study period
- Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
- Active malignancies or any malignant disease within the past 5 years
- Severe uncontrolled diseases that could increase the risk for patients participating in the study
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 |
|---|---|---|
| PURETHAL Birch, 20.000 AUM/mlcomparison of different up-dosing regimes | Biological | conventional regimen of PURETHAL Birch, rush regimen of PURETHAL Birch |
Primary outcome
Proportion of patients successfully reaching the maintenance dose
Time frame: 12 weeks
2 secondary outcomes
Early and late local and systemic reactions
Time frame: 30 minutes after IMP injection and 24 hours after injection
Immunological parameters (IgE, IgG)
Time frame: 10 weeks rush regime, 13 weeks conventional regime
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 11 Apr 2014.
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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.
Piotr Buczyłko, Prof. principal investigator
NZOZ Centrum Alergologii
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PURETHAL Birch, 20.000 AUM/ml in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 8 sites in Poland.
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 6 inclusion and 19 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients successfully reaching the maintenance dose (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2014.