Perennial Allergic Rhinitis
Conditions
Interventions
Stage I
Chlorpheniramine group (experimental): Chlorpheniramine maleate (0.4%), 2 sprays in each nostril, 4 times a day, for 28 days.
Placebo group (control): Placebo: 2 sprays in each nostril, 4 time
Sponsors
APEX DRUG HOUSE
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age and Gender: 1. Male and female patients over 18 years of age. Diagnosis of Perennial Allergic Rhinitis (PRA): 1. Documented history of RAP for at least 1 year. 2. Confirmation of IgE-mediated hypersensitivity to perennial allergens (for example, dust mites, mold, cat or dog dander), demonstrated by: a)Skin prick test: Wheal with a diameter =5 mm larger than the negative control, with a positive histamine control (>5 mm). b) Measurement of specific IgE in serum. - Ability to Participate: 1. Willingness and ability to comply with the protocol requirements and attend scheduled visits. - Health Status: 1. Good general health, with no significant medical conditions that interfere with the interpretation of the results. - - - Consent: 1. Ability to provide written informed consent. cheduled visits.
Exclusion criteria
Exclusion criteria: - Nasal Conditions: 1. Superficial erosion or ulceration of the nasal mucosa. 2. Clinically significant nasal polyposis or severe structural abnormalities. 3. Chronic recurrent sinusitis (>3 episodes per year). - Respiratory Diseases: 1. Active or recent respiratory infections (500 ms). 2. Clinically diagnosed obstructive sleep apnea syndrome. - Other Exclusions: 1. Known hypersensitivity to chlorpheniramine maleate or its components. 2. Nasal or sinus surgery in the last year. 3. Pregnancy or breastfeeding. 4. Inability to give informed consent or comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total nasal symptoms (It is evaluated using the Total Nasal Symptoms Questionnaire (TNSS)). Measurement time: Stage I: At baseline and, 7, 14 and, 28 days after treatment started. Stage II: At baseline, 7, 14 and, 28 days and, 3 and 6 months after treatment started. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (It is evaluated according to the score for each of the items and the total score of the following questionnaires: Sino-nasal Symptoms Questionnaire (SNOT-22), Leicester Cough Questionnaire (LCQ), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)).Measurement time: Stage I: At baseline and, 7, 14 and, 28 days after treatment started. Stage II: At baseline, 7, 14 and, 28 days and, 3 and 6 months after treatment started. 2. Adverse Events-AE (Occurrence of any AE in the subject (yes/no), Description of the AE (Name of the adverse event), Duration of the EA (Difference in dates between the start and end of the event), AE intensity (Mild, Moderate, Severe), Severity of the AE (Serious/serious, Not serious/not serious), Attitude towards the study treatment (no changes, dose modification, temporary or permanent interruption of the study treatment), Result of the AE (recovered, improved, persists or sequelae), Causality relationship (1. Very Likely, 2. Probable, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluable)). Measurement time: Stage I: At baseline and, 7, 14 and, 28 days after treatment started. Stage II: At baseline, 7, 14 and, 28 days and, 3 and 6 months after treatment started. | — |
Countries
Cuba
Contacts
Public ContactIglermys Figueroa Garcia
“Hermanos Ameijeiras” Surgical Clinical Hospital
Outcome results
None listed