Overview

Chlorpheniramine Maleate Nasal Spray for Chronic Rhinitis

Status:
Active, not recruiting
Trial end date:
2021-12-30
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Marcos Sanchez-Gonzalez, MD, PhD
Treatments:
Chlorpheniramine
Criteria
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