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PURETHAL Birch RUSH Study

Primary Purpose

Allergic Rhinitis, Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
PURETHAL Birch, 20.000 AUM/ml
Sponsored by
HAL Allergy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring immunotherapy, birch pollen, seasonal allergy, up-dosing

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.
  • NZOZ Alergia
  • NZOZ ClinicaVitae
  • Medica Pro Familia Sp.zo.o S.K.A
  • ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.
  • Specjalistyczne Centrum Medyczne CenterMed
  • NZOZ CUM PROXIMUM Sp. z o.o.
  • NZOZ Centrum Alergologii

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional regimen of PURETHAL Birch

rush regimen of PURETHAL Birch

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Proportion of patients successfully reaching the maintenance dose

Secondary Outcome Measures

Early and late local and systemic reactions
Immunological parameters (IgE, IgG)

Full Information

First Posted
August 7, 2013
Last Updated
April 10, 2014
Sponsor
HAL Allergy
Collaborators
Ergomed
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1. Study Identification

Unique Protocol Identification Number
NCT01918956
Brief Title
PURETHAL Birch RUSH 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HAL Allergy
Collaborators
Ergomed

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Keywords
immunotherapy, birch pollen, seasonal allergy, up-dosing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional regimen of PURETHAL Birch
Arm Type
Active Comparator
Arm Description
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).
Arm Title
rush regimen of PURETHAL Birch
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
PURETHAL Birch, 20.000 AUM/ml
Intervention Description
comparison of different up-dosing regimes
Primary Outcome Measure Information:
Title
Proportion of patients successfully reaching the maintenance dose
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Early and late local and systemic reactions
Time Frame
30 minutes after IMP injection and 24 hours after injection
Title
Immunological parameters (IgE, IgG)
Time Frame
10 weeks rush regime, 13 weeks conventional regime

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Buczyłko, Prof.
Organizational Affiliation
NZOZ Centrum Alergologii
Official's Role
Principal Investigator
Facility Information:
Facility Name
NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.
City
Białystok
ZIP/Postal Code
15-183
Country
Poland
Facility Name
NZOZ Alergia
City
Bielsko-biała
ZIP/Postal Code
43-300
Country
Poland
Facility Name
NZOZ ClinicaVitae
City
Gdańsk
ZIP/Postal Code
80-405
Country
Poland
Facility Name
Medica Pro Familia Sp.zo.o S.K.A
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
Facility Name
ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Specjalistyczne Centrum Medyczne CenterMed
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
NZOZ CUM PROXIMUM Sp. z o.o.
City
Wrocław
ZIP/Postal Code
53-428
Country
Poland
Facility Name
NZOZ Centrum Alergologii
City
Łódz
ZIP/Postal Code
90-553
Country
Poland

12. IPD Sharing Statement

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PURETHAL Birch RUSH Study

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