Allergic rhinitis
Conditions
Interventions
There are two groups of patients, one of the non-allergic patients and one of the allergic patients. Everyone will receive the two interventions.
Control Group - Puncture Skin Test: It is performed on
Nasal Provocation Tests
Sponsors
National Center of Bioproducts (BioCen)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion 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. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reactivity of the nasal mucosa (Score according to the Lebel scale). Measurement time: 15 minutes after Nasal Provocation Test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cutaneous reactivity (Average wheal diameter in mm). Measurement time: 15 minutes after Puncture Skin Test. 2. Adverse events-AE (Occurrence of some AE in the patient (Yes, No), Description of the AE (Name of adverse event), According to available previous information (Unexpected, Expected), According to its localization the expected AE (World Allergy Organization Criteria: local and systemic AE (0= Nonspecific Symptoms, I= Mild systemic reactions, II= Moderate systemic reactions, III= Severe (nonlife-threatening) systemic reactions, IV= Anaphylactic shock)), Duration of the AE (Difference of dates between the beginning and the end of the AE), Intensity of the AE (Light, Moderate, Severe), Seriousness of the AE (Serious, No serious) - Attitude regarding the procedure in study (Without changes, Dose modification, Temporary interruption, Definitive interruption), Result of the AE (Recovered, Improved, Persists, Sequels), Causal Relationship of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated)). Measurement time: after every test and, 72 hours. | — |
Countries
Cuba
Contacts
Public ContactRaul Castro Almarales
National Center for Biopreparations (BioCen), Clinical Trials Group
Outcome results
None listed