PURETHAL Birch RUSH Study

This study has been completed.
Sponsor:
Collaborator:
Ergomed
Information provided by (Responsible Party):
HAL Allergy
ClinicalTrials.gov Identifier:
NCT01918956
First received: August 7, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Biological: PURETHAL Birch, 20.000 AUM/ml
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by HAL Allergy:

Primary Outcome Measures:
  • Proportion of patients successfully reaching the maintenance dose [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Early and late local and systemic reactions [ Time Frame: 30 minutes after IMP injection and 24 hours after injection ] [ Designated as safety issue: Yes ]
  • Immunological parameters (IgE, IgG) [ Time Frame: 10 weeks rush regime, 13 weeks conventional regime ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2013
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918956

Locations
Poland
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
NZOZ CUM PROXIMUM Sp. z o.o.
Wrocław, Poland, 53-428
NZOZ Centrum Alergologii
Łódz, Poland, 90-553
Sponsors and Collaborators
HAL Allergy
Ergomed
Investigators
Principal Investigator: Piotr Buczyłko, Prof. NZOZ Centrum Alergologii
  More Information

No publications provided

Responsible Party: HAL Allergy
ClinicalTrials.gov Identifier: NCT01918956     History of Changes
Other Study ID Numbers: PB/0040
Study First Received: August 7, 2013
Last Updated: April 10, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by HAL Allergy:
immunotherapy
birch pollen
seasonal allergy
up-dosing

Additional relevant MeSH terms:
Rhinitis
Conjunctivitis, Allergic
Conjunctivitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on August 26, 2014