Chlorpheniramine Maleate Nasal Spray for Chronic Rhinitis

NCT04790487 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: LCH-6-072019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nasal Spray; Chlorpheniramine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Chlorpheniramine

EXPERIMENTAL

Chlorpheniramine (CPM)

Drug: CPM

Control

PLACEBO COMPARATOR

Saline

Drug: Placebo

Interventions

CPM DRUG

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

Also known as: Chlorpheniramine

Chlorpheniramine

Placebo DRUG

Saline

Also known as: PLB

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No oral steroids
• No oral antihistamine
• 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.

You may not qualify if:

• Large (grade 3) polyps, indicating severe nasal obstruction
• Surgical treatment for nasal polyps during the last 3 months
• Cystic fibrosis
• Purulent nasal infection
• Allergic rhinitis
• Any disease likely to interfere with the study parameters or which gave evidence of any serious or unstable concurrent disease or psychological disorder

Sponsors & Collaborators

• Larkin Community Hospital: lead

Study Sites (1)

Larkin Health System

South Miami, Florida, 33143, United States

Location

Related Publications (1)

• 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.

  PMID: 11332874 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic; Nasal Obstruction

Interventions

Chlorpheniramine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marcos A Sanchez-Gonzalez

  Larkin Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups placebo control

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 10, 2021
• Study Start: July 30, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)