Allergic Rhinitis Clinical Trial
Official title:
A Randomized Placebo Control Trial to Evaluate the Efficacy of Chlorpheniramine Maleate Nasal Spray vs. Placebo for Acute or Chronic Rhinitis
Verified date | October 2023 |
Source | Larkin Community Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Allergic rhinitis is defined as the symptoms of sneezing, nasal itching, airflow obstruction, and, mostly, clear nasal discharge caused by IgE-mediated reactions against inhaled allergens and involving mucosal inflammation driven by T cells (Th2) auxiliary type 2. pollens and molds, as well as allergens from perennial interiors, such as dust mites, pets, pests, and some molds. The pattern of dominant allergens depends on the geographic region and degree of urbanization, but the general prevalence of sensitization to allergens does not vary among census districts in the United States. This research proposes to study a separate antihistamine in a nasal spray. It is important to note that this antihistamine is available without prescription (OTC) and has been studied intranasal since the 1950s1
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. No oral steroids 2. No oral antihistamine 3. No Nafasoline If the patient needs rescue treatment, he will go to the intervention arm with chlorpheniramine or with the combination of chlorpheniramine and fluticasone. If a participant experienced a severe acute nasal block, the investigator could authorize the use of a short course of oxymetazoline spray for a maximum of 3 days and a maximum total of 1 day during the treatment period. Oxymetazoline should not be used within 24 hours of a scheduled visit during the study. Exclusion Criteria: 1. Large (grade 3) polyps, indicating severe nasal obstruction 2. Surgical treatment for nasal polyps during the last 3 months 3. Cystic fibrosis 4. Purulent nasal infection 5. Allergic rhinitis 6. Any disease likely to interfere with the study parameters or which gave evidence of any serious or unstable concurrent disease or psychological disorder |
Country | Name | City | State |
---|---|---|---|
United States | Larkin Health System | South Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Larkin Community Hospital |
United States,
Van Toor BS, Buchwald A, Stengele E, Trenk D, Gercek C, de Mey CM. Systemic bioavailability of nasally applied chlorphenamine maleate (0.4% nasal spray) relative to tablets administered perorally. Int J Clin Pharmacol Ther. 2001 Apr;39(4):173-8. doi: 10.5414/cpp39173. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily Symptom Score (DSS) | Allergy daily symptoms score The daily symptom score (DSS) consists of six individual symptom scores: four nasal symptoms (runny nose, blocked nose, sneezing, and itchy nose) and two ocular symptoms (gritty feeling or red or itchy eyes, and watery eyes). 0 to 3: 0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; and 3 = severe symptoms for a max of 18 | 30 days | |
Primary | Visual Analogue Scale (VAS) | visual analogue scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The scale goes from 0 (no symptoms) to 10 (most severe) | 30 days |
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