PURETHAL Grasses Rush Study

February 9, 2012 updated by: HAL Allergy

A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie
      • Dortmund, Germany, 44263
        • Practice Blum
      • Dresden, Germany, 01307
        • Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO
      • Duisburg, Germany, 47051
        • Practice Thieme
      • Frankfurt, Germany, 60596
        • Medaimun GmbH
      • Herford, Germany, 32052
        • Practice Wrede
      • Koblenz, Germany, 56072
        • Dr. med. Jörg Michael Nebel
      • Mahlow, Germany, 15831
        • Practice Scholz
      • Mönchengladbach, Germany, 41069
        • St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie
      • Stuttgart, Germany, 70499
        • Practice Termeer
      • Wiesbaden, Germany, D - 65183
        • Zentrum für Rhinologie & Allergologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Drug: PURETHAL Grasses, 20.000 AUM/ml
subcutaneous injections of increasing doses according to the described regimen
Experimental: 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).
Drug: PURETHAL Grasses, 20.000 AUM/ml
subcutaneous injections of increasing doses according to the described regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
systemic reactions > grade I or large local reactions related to injection
Time Frame: 24 hrs after injection
24 hrs after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
specific serum IgE and IgG concentrations
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HAL Allergy

Investigators

  • Study Chair: Oliver Pfaar, MD, Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

February 10, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/0035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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