PURETHAL Birch RUSH Study

Phase 4

Completed

• Conditions: Allergic Rhinoconjunctivitis; Allergic Rhinitis
• Interventions: Biological: PURETHAL Birch, 20.000 AUM/ml

• Registration Number: NCT01918956
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-08
• Study Start: 2013-09
• Primary Completion: 2014-02
• Status Verified: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional regimen of PURETHAL Birch	PURETHAL Birch, 20.000 AUM/ml	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).
rush regimen of PURETHAL Birch	PURETHAL Birch, 20.000 AUM/ml	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).

Primary Outcome Measures

Name	Time	Method
Proportion of patients successfully reaching the maintenance dose	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (8)

NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.; 🇵🇱 Białystok, Poland

Medica Pro Familia Sp.zo.o S.K.A; 🇵🇱 Katowice, Poland

NZOZ CUM PROXIMUM Sp. z o.o.; 🇵🇱 Wrocław, Poland

ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.; 🇵🇱 Tarnów, Poland

NZOZ Centrum Alergologii; 🇵🇱 Łódz, Poland

NZOZ Alergia; 🇵🇱 Bielsko-biała, Poland

NZOZ ClinicaVitae; 🇵🇱 Gdańsk, Poland

Specjalistyczne Centrum Medyczne CenterMed; 🇵🇱 Tarnów, Poland