PURETHAL Grasses Rush Study

NCT ID: NCT01059266

Last Updated: 2012-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-09-30

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.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional regimen of PURETHAL Grasses

Initial treatment:

6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml (week 1, 2, 3, 4, 5, 6).

Maintenance treatment:

0.5 ml in intervals according to registered scheme (week 8, 10, 12, 16).

Group Type: ACTIVE_COMPARATOR

PURETHAL Grasses, 20.000 AUM/ml

Intervention Type: DRUG

subcutaneous injections of increasing doses according to the described regimen

rush regimen of PURETHAL Grasses

Initial treatment:

3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml (week 1, 2, 3)

Maintenance treatment:

3 monthly doses of 0.5 ml (week 7, 11, 15).

Group Type: EXPERIMENTAL

PURETHAL Grasses, 20.000 AUM/ml

Intervention Type: DRUG

subcutaneous injections of increasing doses according to the described regimen

Interventions

PURETHAL Grasses, 20.000 AUM/ml

subcutaneous injections of increasing doses according to the described regimen

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HAL Allergy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Pfaar, MD

Role: STUDY_CHAIR

Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden

Locations

Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie

Bonn, , Germany

Practice Blum

Dortmund, , Germany

Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO

Dresden, , Germany

Practice Thieme

Duisburg, , Germany

Medaimun GmbH

Frankfurt, , Germany

Practice Wrede

Herford, , Germany

Dr. med. Jörg Michael Nebel

Koblenz, , Germany

Practice Scholz

Mahlow, , Germany

St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie

Mönchengladbach, , Germany

Practice Termeer

Stuttgart, , Germany

Zentrum für Rhinologie & Allergologie

Wiesbaden, , Germany

Countries

Germany

Other Identifiers

P/0035

Identifier Type: -

Identifier Source: org_study_id