PURETHAL Grasses Rush Study

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059266
• Other study ID #: P/0035
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2010
• Last updated: February 9, 2012
• Start date: February 2010
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: HAL Allergy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Intervention

Drug:
• PURETHAL Grasses, 20.000 AUM/ml
subcutaneous injections of increasing doses according to the described regimen

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
HAL Allergy

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systemic reactions > grade I or large local reactions related to injection		24 hrs after injection	Yes
Secondary	specific serum IgE and IgG concentrations		16 weeks	No