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Biological Potency of the Cat Epithelial Allergenic Extracts

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.
 
ClinicalTrials.gov Identifier: NCT01740024
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.

Tracking Information
First Submitted Date  ICMJE November 13, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date May 22, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
Wheal size area (mm2)elicited on the skin after the dose-response prick-test [ Time Frame: Test sites should be inspected and recorded 15-20 min after application ]
Wheal size area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the native and depigmented polymerized cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
  • Wheal size area (mm2)elicited on the skin after the dose-response prick-test [ Time Frame: Test sites should be inspected and recorded 15-20 min after application ]
    Wheal size area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the native and depigmented cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
  • Wheal siza area (mm2)elicited on the skin after the dose-response prick-test [ Time Frame: Test sites should be inspected and recorded 15-20 min after application ]
    Wheal siza area (mm2)elicited on the skin after the dose-response prick-test, in duplicate, of the depigmented and depigmented polymerized cat epithelial allergenic extracts, together with the area of the wheals induced by the positive and negative controls.
  • Determine the HEP dose of the native (N) cat epithelial allergenic extract [ Time Frame: Wheals will be elicited in visit 2. CRFs will be retrieved, measured in-house and filed back in the site before study closure (maximum 3 months after being elicited). ]
    Calculation will be made of the 10 HEP dose of the native (N) cat epithelial allergenic extract.
  • Loss of in vitro potency of the cat epithelial allergenic extracts [ Time Frame: Blood will be collected in visit 2. Serum samples will be analyze once every sample is received. The samples will be analyzed at most 12 months after received ]
    To quantify the loss of in vitro potency of cat epithelial allergenic extracts, based on specific IgE and IgG inhibition studies.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biological Potency of the Cat Epithelial Allergenic Extracts
Official Title  ICMJE An Open-label, Multicentre Study Comparing the Biological Potency of the Native, Depigmented and Depigmented Polymerized Cat Epithelial Allergenic Extracts.
Brief Summary The primary objective of this clinical trial is to quantify the loss of in vivo biological potency of a depigmented polymerized (DPP) allergenic cat epithelial extract versus the native allergenic extract (N).
Detailed Description

This is an open-label, non-randomized phase II clinical trial.

Three different concentrations of three different cat epithelial allergenic extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride and a glycerated phenol saline solution, respectively, will be tested in every subject on the volar surface of the forearm.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Cat Allergy (Disorder)
Intervention  ICMJE Biological: 1 (Dose Response Skin Prick Tests)
3 different cat epithelium allergenic extracts at 3 different concentrations, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Study Arms  ICMJE Experimental: 1 (Dose-Response Skin Prick Tests)
3 different cat epithelium allergenic extracts at 3 different concentrations Positive control Negative control
Intervention: Biological: 1 (Dose Response Skin Prick Tests)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2014)
35
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2012)
30
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A subject will be eligible for inclusion in the study only if all of the following criteria are met:

  • The subject (and/or legal representative, where applicable) has given written, signed and dated informed consent.
  • Subjects of either sex and of any race or ethnic group.
  • Age > 18 years and < 60 years on the day of inclusion in the study.
  • Positive clinical history of allergy to cat epithelia (i.e., rhinitis, conjunctivitis, rhinoconjunctivitis, asthma, urticaria, etc. ).
  • A positive prick-test (mean diameter of papule ≥ 3 mm or area of papule ≥ 7 mm2) with a commercial extract of cat epithelium. The results of the prick-test will be valid if they were obtained in the year prior to inclusion of the subject in the study.
  • A positive specific IgE test (> 0.70 KU/l) for cat epithelium. The results of the IgE test will be valid if they were obtained in the year prior to inclusion of the subject in the study.

Exclusion Criteria:

A subject will NOT be eligible for inclusion in the study if any of the following criteria are met:

  • Immunotherapy in the last 5 years involving allergens known to be able to interfere with the test allergen (e.g., cat extract).
  • Use of drugs that can interfere with the skin response before and during the study (e.g., antihistamines), within the intervals established in section 9.1 and appendix 1.
  • Treatment with any of the following medicines: tricyclic or tetracyclic antidepressants or MAOIs (Monoamine oxidase inhibitors), beta-blockers or chronic use of oral corticosteroids or use of corticosteroids via either the oral or the parenteral route in repeated and intermittent dosing regimens (> 10 mg/day of prednisone or equivalent).
  • Pregnant or nursing women and women with a positive pregnancy test in visit 2.
  • Dermographism affecting the skin of the test site, in either of the two visits to the study centre.
  • Atopic dermatitis affecting the skin of the test site, in either of the two visits to the study centre.
  • Urticaria affecting the skin of the test site, in either of the two visits to the study centre.
  • Clinically relevant immune system diseases (both autoimmune disorders and immune deficiencies). (Hashimoto's thyroiditis with hypothyroidism well controlled through thyroid hormone therapy does not necessarily represent a contraindication. Graves' disease (hyperthyroidism) would be an exclusion criterion due to the potential risk in the event adrenaline must be used.)
  • Serious uncontrolled diseases that may increase the safety risk of the subjects participating in the study, including but not limited to the following: heart failure, serious or uncontrolled respiratory diseases, endocrine disorders, clinically relevant liver or kidney diseases, or haematological disorders.
  • Patents with diseases or conditions that limit adrenaline use (coronary disease, severe arterial hypertension, etc.).
  • Serious psychiatric, psychological or neurological problems.
  • Medication, alcohol or illegal drug abuse in the last year.
  • Participation in any other clinical trial during the 30 days (or 5 times the biological half-life of the investigational product - whichever is longest) prior to inclusion of the subject in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740024
Other Study ID Numbers  ICMJE 206-PG-PRI-190
2012-001931-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratorios Leti, S.L.
Study Sponsor  ICMJE Laboratorios Leti, S.L.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lena M Erbiti Laboratorios LETI, S.L.Unipersonal
PRS Account Laboratorios Leti, S.L.
Verification Date November 2012

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