PURETHAL Grasses Rush Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HAL Allergy
ClinicalTrials.gov Identifier:
NCT01059266
First received: January 28, 2010
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Allergic Rhinitis
Allergic Rhinoconjunctivitis
Drug: PURETHAL Grasses, 20.000 AUM/ml
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by HAL Allergy:

Primary Outcome Measures:
  • systemic reactions > grade I or large local reactions related to injection [ Time Frame: 24 hrs after injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • specific serum IgE and IgG concentrations [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059266

Locations
Germany
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
Investigators
Study Chair: Oliver Pfaar, MD Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden
  More Information

No publications provided

Responsible Party: HAL Allergy
ClinicalTrials.gov Identifier: NCT01059266     History of Changes
Other Study ID Numbers: P/0035
Study First Received: January 28, 2010
Last Updated: February 9, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by HAL Allergy:
immunotherapy
grass pollen
seasonal allergy
dose tolerability

Additional relevant MeSH terms:
Rhinitis
Conjunctivitis, Allergic
Conjunctivitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on August 28, 2014