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PURETHAL Grasses Rush Study

Primary Purpose

Allergic Rhinitis, Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
PURETHAL Grasses, 20.000 AUM/ml
Sponsored by
HAL Allergy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring immunotherapy, grass pollen, seasonal allergy, dose tolerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie
  • Practice Blum
  • Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO
  • Practice Thieme
  • Medaimun GmbH
  • Practice Wrede
  • Dr. med. Jörg Michael Nebel
  • Practice Scholz
  • St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie
  • Practice Termeer
  • Zentrum für Rhinologie & Allergologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional regimen of PURETHAL Grasses

rush regimen of PURETHAL Grasses

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

specific serum IgE and IgG concentrations

Full Information

First Posted
January 28, 2010
Last Updated
February 9, 2012
Sponsor
HAL Allergy
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1. Study Identification

Unique Protocol Identification Number
NCT01059266
Brief Title
PURETHAL Grasses Rush Study
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HAL Allergy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Keywords
immunotherapy, grass pollen, seasonal allergy, dose tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional regimen of PURETHAL Grasses
Arm Type
Active Comparator
Arm Description
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).
Arm Title
rush regimen of PURETHAL Grasses
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
PURETHAL Grasses, 20.000 AUM/ml
Intervention Description
subcutaneous injections of increasing doses according to the described regimen
Primary Outcome Measure Information:
Title
systemic reactions > grade I or large local reactions related to injection
Time Frame
24 hrs after injection
Secondary Outcome Measure Information:
Title
specific serum IgE and IgG concentrations
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Pfaar, MD
Organizational Affiliation
Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Practice Blum
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
Facility Name
Uni-Klinikum Carl Gustav Carus Klinik und Poliklinik für HNO
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Practice Thieme
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Medaimun GmbH
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Practice Wrede
City
Herford
ZIP/Postal Code
32052
Country
Germany
Facility Name
Dr. med. Jörg Michael Nebel
City
Koblenz
ZIP/Postal Code
56072
Country
Germany
Facility Name
Practice Scholz
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
St. Kamillus Krankenhaus Abt. Lungen- und Bronchialheilkunde und Allergologie
City
Mönchengladbach
ZIP/Postal Code
41069
Country
Germany
Facility Name
Practice Termeer
City
Stuttgart
ZIP/Postal Code
70499
Country
Germany
Facility Name
Zentrum für Rhinologie & Allergologie
City
Wiesbaden
ZIP/Postal Code
D - 65183
Country
Germany

12. IPD Sharing Statement

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PURETHAL Grasses Rush Study

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