Efficacy of nasal provocation test with VALERGEN-DP, DS and BT

Phase 2

• Conditions: Allergic rhinitis; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Immune System Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity

• Registration Number: RPCEC00000301
• Lead Sponsor: ational Center of Bioproducts (BioCen)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-15
• Study Completion: 2022-12-07
• Results First Posted: 2023-04-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 300

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.
3) Non-allergic individuals with a skin prick test with allergen extracts investigated (VALERGEN-DP, VALERGEN-DS and VALERGEN-BT at 20,000 UB/mL), negative (wheal diameter <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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reactivity of the nasal mucosa (Score according to the Lebel scale). Measurement time: 15 minutes after Nasal Provocation Test