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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

January 28, 2010
February 9, 2012
February 2010
September 2010   (final data collection date for primary outcome measure)
systemic reactions > grade I or large local reactions related to injection [ Time Frame: 24 hrs after injection ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01059266 on ClinicalTrials.gov Archive Site
specific serum IgE and IgG concentrations [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
PURETHAL Grasses Rush Study
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Allergic Rhinitis
  • Allergic Rhinoconjunctivitis
Drug: PURETHAL Grasses, 20.000 AUM/ml
subcutaneous injections of increasing doses according to the described regimen
  • 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).

    Intervention: Drug: PURETHAL Grasses, 20.000 AUM/ml
  • 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).

    Intervention: Drug: PURETHAL Grasses, 20.000 AUM/ml
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01059266
P/0035
No
HAL Allergy
HAL Allergy
Not Provided
Study Chair: Oliver Pfaar, MD Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden
HAL Allergy
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP