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Clinical Trials/RPCEC00000301
RPCEC00000301
Not yet recruiting
Phase 2

Diagnostic efficacy of the nasal provocation test in patients with allergic rhinitis sensitive to house dust mites.

ational Center of Bioproducts (BioCen)0 sites300 target enrollmentApril 15, 2019

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Allergic rhinitis
Sponsor
ational Center of Bioproducts (BioCen)
Enrollment
300
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 15, 2019
End Date
December 7, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
ational Center of Bioproducts (BioCen)

Eligibility Criteria

Inclusion Criteria

  • Allergic group (Group A):
  • 1\) Patients with a positive clinical history of persistent allergic rhinitis to home dust, according to the diagnostic criteria.
  • 2\) Age between 18 and 50 years.
  • 3\) Patients with a skin prick test with allergen extracts investigated (VALERGEN\-DP, VALERGEN\-DS and VALERGEN\-BT 20 000 UB/ mL), negative (diameter of wheal \<3 mm).
  • 4\) People of any sex who express their informed consent in writing to participate in the study.
  • 5\) Negative nasal discharge.
  • 6\) Physical Examination of anterior nostril negative for allergic rhinitis.
  • \- Non\-allergic group (Group B):
  • 1\) Non\-allergic subjects without a positive clinical history of persistent allergic rhinitis to house dust, according to the diagnostic criteria described.
  • 2\) Age between 18 and 50 years.

Exclusion Criteria

  • 1\) Patients treated by Immunotherapy with allergenic extracts of D. pteronyssinus, D. siboney, D. farinae, B. tropical or home dust in the last two years.
  • 2\) Patients with symptoms of asthma, otitis media with effusion, acute sinusitis, rhinitis or conjunctivitis at the time of the tests.
  • 3\) Current use of drugs that interfere with the cutaneous and nasal reaction of the tests to be performed, which must be previously suspended.
  • 4\) Dermographism, atopic dermatitis in the area of skin test and urticaria.
  • 5\) Patients who do not express their written consent to participate in the study.

Outcomes

Primary Outcomes

Not specified

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