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Trial record 2 of 87 for:    chlorpheniramine

Chlorpheniramine Maleate Nasal Spray for Chronic Rhinitis

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ClinicalTrials.gov Identifier: NCT04790487
Recruitment Status : Active, not recruiting
First Posted : March 10, 2021
Last Update Posted : April 27, 2021
Information provided by (Responsible Party):
Marcos Sanchez-Gonzalez, MD, PhD, Larkin Community Hospital

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Nasal Congestion Drug: CPM Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups placebo control
Masking: Double (Participant, Care Provider)
Masking Description: double-blinded
Primary Purpose: Treatment
Official Title: A Randomized Placebo Control Trial to Evaluate the Efficacy of Chlorpheniramine Maleate Nasal Spray vs. Placebo for Acute or Chronic Rhinitis
Actual Study Start Date : July 30, 2019
Actual Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Arm Intervention/treatment
Experimental: Chlorpheniramine
Chlorpheniramine (CPM)
Drug: CPM
one spray dose (~100 µL of the solution containing 1.25 mg CPM) per nostril twice a day
Other Name: Chlorpheniramine

Placebo Comparator: Control
Drug: Placebo
Other Name: PLB

Primary Outcome Measures :
  1. Daily Symptom Score (DSS) [ Time Frame: 30 days ]
    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

  2. Visual Analogue Scale (VAS) [ Time Frame: 30 days ]
    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)

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04790487

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United States, Florida
Larkin Health System
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Marcos Sanchez-Gonzalez, MD, PhD
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Principal Investigator: Marcos A Sanchez-Gonzalez Larkin Health System
Publications of Results:
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Responsible Party: Marcos Sanchez-Gonzalez, MD, PhD, Sponsor Investigator, Larkin Community Hospital
ClinicalTrials.gov Identifier: NCT04790487    
Other Study ID Numbers: LCH-6-072019
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marcos Sanchez-Gonzalez, MD, PhD, Larkin Community Hospital:
Nasal Spray
Additional relevant MeSH terms:
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Rhinitis, Allergic
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents