Clinical trial NCT01918956: PURETHAL Birch RUSH Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Allergic Rhinoconjunctivitis
Keywords: immunotherapy
birch pollen
seasonal allergy
up-dosing
Lead sponsor: HAL Allergy
Sponsor class: INDUSTRY
Collaborators: name: Ergomed
First posted: 2013-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of patients successfully reaching the maintenance dose
timeFrame: 12 weeks
Secondary outcomes:
measure: Early and late local and systemic reactions
timeFrame: 30 minutes after IMP injection and 24 hours after injection
measure: Immunological parameters (IgE, IgG)
timeFrame: 10 weeks rush regime, 13 weeks conventional regime
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J.
city: Bielsko-biała
country: Poland
facility: NZOZ Alergia
city: Gdańsk
country: Poland
facility: NZOZ ClinicaVitae
city: Katowice
country: Poland
facility: Medica Pro Familia Sp.zo.o S.K.A
city: Tarnów
country: Poland
facility: ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o.
city: Tarnów
country: Poland
facility: Specjalistyczne Centrum Medyczne CenterMed
city: Wrocław
country: Poland
facility: NZOZ CUM PROXIMUM Sp. z o.o.
city: Łódz
country: Poland
facility: NZOZ Centrum Alergologii
Study officials:
affiliation: NZOZ Centrum Alergologii
name: Piotr Buczyłko, Prof.
role: PRINCIPAL_INVESTIGATOR
References: