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Clinical Trials/EUCTR2009-015012-18-DE
EUCTR2009-015012-18-DE
Active, not recruiting
Not Applicable

A prospective, randomized, open, multi-centre study to assess safety of PURETHAL Grasses given with a rush induction schedule to patients with allergic rhinoconjunctivitis. - PURETHAL Grasses Rush study

HAL Allergy BV0 sitesNovember 19, 2009
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ConditionsAllergic (IgE-mediated) rhinitis/rhinoconjunctivitis due to sensitization to grass pollenMedDRA version: 12.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisMedDRA version: 12.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenMedDRA version: 12.0Level: LLTClassification code 10053741Term: Allergenic desensitization procedure
DrugsPURETHAL Gräser

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Allergic (IgE-mediated) rhinitis/rhinoconjunctivitis due to sensitization to grass pollen
Sponsor
HAL Allergy BV
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 19, 2009
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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 (see appendix 2\) 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

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 b\-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.

Outcomes

Primary Outcomes

Not specified

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