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PURETHAL Grasses Rush Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059266
Recruitment Status : Completed
First Posted : January 29, 2010
Last Update Posted : February 10, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Rhinoconjunctivitis Drug: PURETHAL Grasses, 20.000 AUM/ml Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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

Primary Outcome Measures :
  1. systemic reactions > grade I or large local reactions related to injection [ Time Frame: 24 hrs after injection ]

Secondary Outcome Measures :
  1. specific serum IgE and IgG concentrations [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059266

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Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie
Bonn, Germany, 53127
Practice Blum
Dortmund, Germany, 44263
Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO
Dresden, Germany, 01307
Practice Thieme
Duisburg, Germany, 47051
Medaimun GmbH
Frankfurt, Germany, 60596
Practice Wrede
Herford, Germany, 32052
Dr. med. Jörg Michael Nebel
Koblenz, Germany, 56072
Practice Scholz
Mahlow, Germany, 15831
St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie
Mönchengladbach, Germany, 41069
Practice Termeer
Stuttgart, Germany, 70499
Zentrum für Rhinologie & Allergologie
Wiesbaden, Germany, D - 65183
Sponsors and Collaborators
HAL Allergy
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Study Chair: Oliver Pfaar, MD Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden

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Responsible Party: HAL Allergy Identifier: NCT01059266    
Other Study ID Numbers: P/0035
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Keywords provided by HAL Allergy:
grass pollen
seasonal allergy
dose tolerability
Additional relevant MeSH terms:
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Rhinitis, Allergic
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases