Status:
COMPLETED
PURETHAL Birch RUSH Study
Lead Sponsor:
HAL Allergy
Collaborating Sponsors:
Ergomed
Conditions:
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief 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 conv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01918956
Start Date
September 1 2013
End Date
April 1 2014
Last Update
April 11 2014
Active Locations (8)
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1
NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.
Bialystok, Poland, 15-183
2
NZOZ Alergia
Bielsko-Biala, Poland, 43-300
3
NZOZ ClinicaVitae
Gdansk, Poland, 80-405
4
Medica Pro Familia Sp.zo.o S.K.A
Katowice, Poland, 40-954