Chlorpheniramine Maleate Nasal Spray for Chronic Rhinitis

NCT04790487 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-10-16

No results posted yet for this study

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

Conditions

  • Allergic Rhinitis
  • Nasal Congestion

Interventions

DRUG

CPM

one spray dose (\~100 µL of the solution containing 1.25 mg CPM) per nostril twice a day

DRUG

Placebo

Saline

Sponsors & Collaborators

  • Larkin Community Hospital

    lead OTHER

Principal Investigators

  • Marcos A Sanchez-Gonzalez · Larkin Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2020-12-30
Completion
2021-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04790487 on ClinicalTrials.gov