PURETHAL Grasses Rush Study

NCT01059266 | Completed Phase 4

• 1 other identifier: P/0035
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 11

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

Keywords

immunotherapy; grass pollen; seasonal allergy; dose tolerability

Outcome Measures

Primary Outcomes (1)

• systemic reactions > grade I or large local reactions related to injection

  24 hrs after injection

Secondary Outcomes (1)

• specific serum IgE and IgG concentrations

  16 weeks

Study Arms (2)

conventional regimen of PURETHAL Grasses

ACTIVE COMPARATOR

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).

Drug: PURETHAL Grasses, 20.000 AUM/ml

rush regimen of PURETHAL Grasses

EXPERIMENTAL

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).

Drug: PURETHAL Grasses, 20.000 AUM/ml

Interventions

PURETHAL Grasses, 20.000 AUM/ml DRUG

subcutaneous injections of increasing doses according to the described regimen

conventional regimen of PURETHAL Grasses; rush regimen of PURETHAL Grasses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HAL Allergy: lead

Study Sites (11)

Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie

Bonn, 53127, Germany

Location

Practice Blum

Dortmund, 44263, Germany

Location

Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO

Dresden, 01307, Germany

Location

Practice Thieme

Duisburg, 47051, Germany

Location

Medaimun GmbH

Frankfurt, 60596, Germany

Location

Practice Wrede

Herford, 32052, Germany

Location

Dr. med. Jörg Michael Nebel

Koblenz, 56072, Germany

Location

Practice Scholz

Mahlow, 15831, Germany

Location

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

Mönchengladbach, 41069, Germany

Location

Practice Termeer

Stuttgart, 70499, Germany

Location

Zentrum für Rhinologie & Allergologie

Wiesbaden, D - 65183, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Oliver Pfaar, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 10, 2012

Record last verified: 2012-02

Locations

DE (11)