PURETHAL Birch RUSH Study

NCT01918956 | Completed Phase 4

• 1 other identifier: PB/0040
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

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.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Keywords

immunotherapy; birch pollen; seasonal allergy; up-dosing

Outcome Measures

Primary Outcomes (1)

• Proportion of patients successfully reaching the maintenance dose

  12 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

conventional regimen of PURETHAL Birch

ACTIVE COMPARATOR

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

rush regimen of PURETHAL Birch

EXPERIMENTAL

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

Interventions

PURETHAL Birch, 20.000 AUM/ml BIOLOGICAL

comparison of different up-dosing regimes

conventional regimen of PURETHAL Birch; rush regimen of PURETHAL Birch

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• HAL Allergy: lead
• Ergomed: collaborator

Study Sites (8)

NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.

Bialystok, 15-183, Poland

Location

NZOZ Alergia

Bielsko-Biala, 43-300, Poland

Location

NZOZ ClinicaVitae

Gdansk, 80-405, Poland

Location

Medica Pro Familia Sp.zo.o S.K.A

Katowice, 40-954, Poland

Location

ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.

Tarnów, 33-100, Poland

Location

Specjalistyczne Centrum Medyczne CenterMed

Tarnów, 33-100, Poland

Location

NZOZ CUM PROXIMUM Sp. z o.o.

Wroclaw, 53-428, Poland

Location

NZOZ Centrum Alergologii

Łódz, 90-553, Poland

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Piotr Buczyłko, Prof.

  NZOZ Centrum Alergologii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 8, 2013
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 11, 2014

Record last verified: 2014-04

Locations

PL (8)