PURETHAL Birch RUSH Study

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918956
• Other study ID #: PB/0040
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2013
• Last updated: April 10, 2014
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: HAL Allergy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 ß-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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis

Intervention

Biological:
• PURETHAL Birch, 20.000 AUM/ml
comparison of different up-dosing regimes

Locations

Country	Name	City	State
Poland	NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.	Bialystok
Poland	NZOZ Alergia	Bielsko-biala
Poland	NZOZ ClinicaVitae	Gdansk
Poland	Medica Pro Familia Sp.zo.o S.K.A	Katowice
Poland	NZOZ Centrum Alergologii	Lódz
Poland	ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnów
Poland	Specjalistyczne Centrum Medyczne CenterMed	Tarnów
Poland	NZOZ CUM PROXIMUM Sp. z o.o.	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
HAL Allergy	Ergomed

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients successfully reaching the maintenance dose		12 weeks	Yes
Secondary	Early and late local and systemic reactions		30 minutes after IMP injection and 24 hours after injection	Yes
Secondary	Immunological parameters (IgE, IgG)		10 weeks rush regime, 13 weeks conventional regime	No