PURETHAL Grasses Rush Study

Phase 4

Completed

• Conditions: Allergic Rhinitis; Allergic Rhinoconjunctivitis
• Interventions: Drug: PURETHAL Grasses, 20.000 AUM/ml

• Registration Number: NCT01059266
• Lead Sponsor: HAL Allergy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Study Start: 2010-02
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional regimen of PURETHAL Grasses	PURETHAL Grasses, 20.000 AUM/ml	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).
rush regimen of PURETHAL Grasses	PURETHAL Grasses, 20.000 AUM/ml	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).

Primary Outcome Measures

Name	Time	Method
systemic reactions > grade I or large local reactions related to injection	24 hrs after injection

Secondary Outcome Measures

Name	Time	Method
specific serum IgE and IgG concentrations	16 weeks

Trial Locations

Locations (11)

Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie; 🇩🇪 Bonn, Germany

Medaimun GmbH; 🇩🇪 Frankfurt, Germany

Practice Blum; 🇩🇪 Dortmund, Germany

St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie; 🇩🇪 Mönchengladbach, Germany

Zentrum für Rhinologie & Allergologie; 🇩🇪 Wiesbaden, Germany

Dr. med. Jörg Michael Nebel; 🇩🇪 Koblenz, Germany

Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO; 🇩🇪 Dresden, Germany

Practice Scholz; 🇩🇪 Mahlow, Germany

Practice Thieme; 🇩🇪 Duisburg, Germany

Practice Wrede; 🇩🇪 Herford, Germany

Practice Termeer; 🇩🇪 Stuttgart, Germany