Biological Stardadization of D. Pteronyssinus and D. Farinae Allergen Extracts

Immune System Diseases Clinical Trial

— MM09  

Official title:

Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Allergen Extract. Determination of the Allergenic Potency in Vivo Histamine Equivalent Units (HEP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527122
• Other study ID #: MM09-STD-011
• Secondary ID: 2013-005394-45
• Status: Completed
• Phase: N/A
• Start date: July 21, 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Inmunotek S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Four concentrations of Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extracts, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm..

Description:

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Clinical history positive inhalation allergy (rhinitis I rhinoconjunctivitis I asthma) against Dermatophagoides pteronyssinus or Dermatophagoides farinae.

• A prick-test positive (average of the papule = 3 mm diameter) with a summary of the same allergen I presence against the allergen specific Immunoglobulin E.

• The average area of the papule obtained by histamine dihydrochloride to 10 mgml must be greater than or equal 7 mm2.

• Age: over 18 years of age.

• Both sexes.

Exclusion Criteria:

• Subjects outside of the age range.

• Individuals who have previously received immunotherapy in the last 5 years for the treatment of asthma or the allergic rhinoconjunctivitis induced by allergens that may interfere with the extract mixture of Dermatophagoides pteronyssinus or farinae.

• Subjects with important symptoms of rhinoconjunctivitis I bronchial asthma in which the suspension of the antihistamine treatment for systemic is contraindicated.

• Subjects that have previously submitted a serious secondary reaction during skin prick test diagnostic tests.

• Subjects in treatment with ss-blockers.

• Unstable subjects of clinical point of view (asthma acute, febrile, etc.).

• Subjects with lesions of active hives, severe active dermographism, severe atopic dermatitis, sunburn, eczema, lesions of psoriasis in the area of realization of the prick test (risk of false positives).

• Subjects with viral infection activates the herpes simplex or herpes varicella-zoster in the area of realization of the prick test.

• Subjects that have some pathology in which the administration of adrenaline (hyperthyroidism, hypertension, heart disease, etc.) is contraindicated.

• States of the subject that can not offer cooperation and severe psychiatric disorders.

• Pregnant or women at risk of pregnancy and breastfeeding women.

Related Conditions & MeSH terms

• Immune System Diseases

Intervention

Diagnostic Test:
• Allergen extracts

Locations

Country	Name	City	State
Spain	Hospital Univ. Ntra. Sra. de la Candelaria	Sta. Cruz de Tenerife	Islas Canarias

Sponsors (1)

Lead Sponsor	Collaborator
Inmunotek S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The wheal size diameter on the skin at the site of the puncture during the immediate phase when applied each concentration of the allergen extract	wheal size diameter OF THE SKIN PRICK TEST	1 hour