Clinical trial NCT01059266: PURETHAL Grasses Rush Study
Official title: A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Allergic Rhinoconjunctivitis
Keywords: immunotherapy
grass pollen
seasonal allergy
dose tolerability
Lead sponsor: HAL Allergy
Sponsor class: INDUSTRY
First posted: 2010-01-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: 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 Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).

The primary parameter will be the proportion of patients who experience systemic reactions \> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.

It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.


Eligibility criteria: Inclusion Criteria

* Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 \> 70%) for at least 2 years related to grass pollen, eligible for SCIT.
* Confirmation of IgE-mediated allergy by means of:

  * Positive SPT to grass pollen (mean wheal diameter ≥ 3 mm and negative control truly negative (no reaction), or
  * Specific serum IgE-test (ssIgE \>0.7 U/ml) for grass pollen, or
  * Positive provocation test for grass pollen.
* Age ≥ 18 years.
* Patients have given a written informed consent

Exclusion Criteria:

* Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value.
* Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV).
* Active inflammation/infection of the target organs (nose, eyes, lungs).
* Severe atopic dermatitis in need for systemic immunosuppressive medication.
* Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension.
* Severe kidney disease.
* Diseases with a contra-indication for the use of adrenaline.
* Treatment with systemic or local beta-blockers or immunosuppressive drugs.
* History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis.
* Any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months.
* Participation in a clinical study with a new investigational drug within the last three months.
* Pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, IUD, condom use if used together with a spermicide and having no sexual relationship with a man).
* Alcohol or drug abuse.
* Lack of co-operation or severe psychological disorders.
* Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
* Low compliance or inability to understand instructions/study documents.
* Completed or ongoing treatment with anti-IgE-antibody.
* Patients being in relationship or dependence with the sponsor or investigator.
* Allergy to any of the excipients.
* Severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study.

Primary outcomes:
measure: systemic reactions > grade I or large local reactions related to injection
timeFrame: 24 hrs after injection
Secondary outcomes:
measure: specific serum IgE and IgG concentrations
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie
city: Dortmund
country: Germany
facility: Practice Blum
city: Dresden
country: Germany
facility: Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO
city: Duisburg
country: Germany
facility: Practice Thieme
city: Frankfurt
country: Germany
facility: Medaimun GmbH
city: Herford
country: Germany
facility: Practice Wrede
city: Koblenz
country: Germany
facility: Dr. med. Jörg Michael Nebel
city: Mahlow
country: Germany
facility: Practice Scholz
city: Mönchengladbach
country: Germany
facility: St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie
city: Stuttgart
country: Germany
facility: Practice Termeer
city: Wiesbaden
country: Germany
facility: Zentrum für Rhinologie & Allergologie
Study officials:
affiliation: Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden
name: Oliver Pfaar, MD
role: STUDY_CHAIR
References: