Cat Allergy (Disorder) Clinical Trial
Official title:
An Open-label, Multicentre Study Comparing the Biological Potency of the Native, Depigmented and Depigmented Polymerized Cat Epithelial Allergenic Extracts.
| Verified date | November 2012 |
| Source | Laboratorios Leti, S.L. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Spanish Agency of Medicines |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital El Tomillar - Area Hospitalaria de Valme | Dos Hermanas, Sevilla | Sevilla / Andalucia |
| Spain | Fundación Jimenez Diaz | Madrid | Madrid / Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Laboratorios Leti, S.L. |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 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 | No |
| Secondary | Wheal siza area (mm2)elicited on the skin after the dose-response prick-test | 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. | Test sites should be inspected and recorded 15-20 min after application | No |
| Secondary | Determine the HEP dose of the native (N) cat epithelial allergenic extract | Calculation will be made of the 10 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). | No |
| Secondary | Loss of in vitro potency of the cat epithelial allergenic extracts | To quantify the loss of in vitro potency of cat epithelial allergenic extracts, based on specific IgE and IgG inhibition studies. | 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 | No |