Biological Potency of the Cat Epithelial Allergenic Extracts

NCT01740024 | Completed Phase 2

• 2 other identifiers: 206-PG-PRI-1902012-001931-30
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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).

Conditions

Cat Allergy (Disorder)

Keywords

Immunotherapy; Subcutaneous immunotherapy; Skin Prick Test; Dose Response Prick Test

Outcome Measures

Primary Outcomes (1)

• Wheal size area (mm2)elicited on the skin after the dose-response prick-test

  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.

  Test sites should be inspected and recorded 15-20 min after application

Secondary Outcomes (4)

• Wheal size area (mm2)elicited on the skin after the dose-response prick-test

  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

  Test sites should be inspected and recorded 15-20 min after application

• Determine the HEP dose of the native (N) cat epithelial allergenic extract

  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).

• Loss of in vitro potency of the cat epithelial allergenic extracts

  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

Study Arms (1)

1 (Dose-Response Skin Prick Tests)

EXPERIMENTAL

3 different cat epithelium allergenic extracts at 3 different concentrations Positive control Negative control

Biological: 1 (Dose Response Skin Prick Tests)

Interventions

1 (Dose Response Skin Prick Tests) BIOLOGICAL

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.

1 (Dose-Response Skin Prick Tests)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Positive clinical history of allergy to cat epithelia (i.e., rhinitis, conjunctivitis, rhinoconjunctivitis, asthma, urticaria, etc. ).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (2)

Fundación Jimenez Diaz

Madrid, Madrid / Madrid, 28005, Spain

Location

Hospital El Tomillar - Area Hospitalaria de Valme

Dos Hermanas, Sevilla, Sevilla / Andalucia, 41700, Spain

Location

Study Officials

• Lena M Erbiti

  Laboratorios LETI, S.L.Unipersonal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 22, 2014

Record last verified: 2012-11

Locations

ES (2)