PURETHAL Birch RUSH Study

April 10, 2014 updated by: HAL Allergy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Białystok, Poland, 15-183
        • NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.
      • Bielsko-biała, Poland, 43-300
        • NZOZ Alergia
      • Gdańsk, Poland, 80-405
        • NZOZ ClinicaVitae
      • Katowice, Poland, 40-954
        • Medica Pro Familia Sp.zo.o S.K.A
      • Tarnów, Poland, 33-100
        • ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.
      • Tarnów, Poland, 33-100
        • Specjalistyczne Centrum Medyczne CenterMed
      • Wrocław, Poland, 53-428
        • NZOZ CUM PROXIMUM Sp. z o.o.
      • Łódz, Poland, 90-553
        • NZOZ Centrum Alergologii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients successfully reaching the maintenance dose
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Early and late local and systemic reactions
Time Frame: 30 minutes after IMP injection and 24 hours after injection
30 minutes after IMP injection and 24 hours after injection
Immunological parameters (IgE, IgG)
Time Frame: 10 weeks rush regime, 13 weeks conventional regime
10 weeks rush regime, 13 weeks conventional regime

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HAL Allergy

Collaborators

Ergomed

Investigators

  • Principal Investigator: Piotr Buczyłko, Prof., NZOZ Centrum Alergologii

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimate)

August 8, 2013

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB/0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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