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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01918956
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : April 11, 2014
Information provided by (Responsible Party):
HAL Allergy

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 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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Rhinoconjunctivitis Biological: PURETHAL Birch, 20.000 AUM/ml Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Active Comparator: conventional regimen of PURETHAL Birch

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).

Biological: PURETHAL Birch, 20.000 AUM/ml
comparison of different up-dosing regimes

Experimental: rush regimen of PURETHAL Birch

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).

Biological: PURETHAL Birch, 20.000 AUM/ml
comparison of different up-dosing regimes

Primary Outcome Measures :
  1. Proportion of patients successfully reaching the maintenance dose [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Early and late local and systemic reactions [ Time Frame: 30 minutes after IMP injection and 24 hours after injection ]
  2. Immunological parameters (IgE, IgG) [ Time Frame: 10 weeks rush regime, 13 weeks conventional regime ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01918956

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NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.
Białystok, Poland, 15-183
NZOZ Alergia
Bielsko-biała, Poland, 43-300
NZOZ ClinicaVitae
Gdańsk, Poland, 80-405
Medica Pro Familia Sp.zo.o S.K.A
Katowice, Poland, 40-954
ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.
Tarnów, Poland, 33-100
Specjalistyczne Centrum Medyczne CenterMed
Tarnów, Poland, 33-100
Wrocław, Poland, 53-428
NZOZ Centrum Alergologii
Łódz, Poland, 90-553
Sponsors and Collaborators
HAL Allergy
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Principal Investigator: Piotr Buczyłko, Prof. NZOZ Centrum Alergologii

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Responsible Party: HAL Allergy Identifier: NCT01918956    
Other Study ID Numbers: PB/0040
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014
Keywords provided by HAL Allergy:
birch pollen
seasonal allergy
Additional relevant MeSH terms:
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Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases