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Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• Subjects must live in a geographical area where allergic problems caused by Quercus ilex and Quercus robur are relevant.

• Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Quercus ilex and Quercus robur.

• A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.

• The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.

• Age: Between 18 and 64 years old.

• Subjects must be able to give informed consent.

Locations
Other Locations
Spain
Clínica Subiza, centro de asma y alergia
RECRUITING
Madrid
Contact Information
Primary
Miguel Casanovas, MD
mcasanovas@inmunotek.com
+34912908942
Backup
Raquel Caballero, BSc
rcaballero@inmunotek.com
+34607600638
Time Frame
Start Date: 2023-01-24
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 30
Treatments
Experimental: Extract Q. ilex + extract Q. robur + positive control + negative control
There is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10mg/mL) and the negative control, with prick test.~Quercus ilex: 2,500, 500 and 100 μg/mL Quercus robur: 2,500, 500 and 100 μg/mL
Related Therapeutic Areas
Sponsors
Leads: Inmunotek S.L.

This content was sourced from clinicaltrials.gov