Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants (FEXPOLSAR)

Phase 3, Single-center, Sequential and Parallel-group, Double-blind, Randomized Study Evaluating the Efficacy and Safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) Versus Placebo in Subjects Suffering From Seasonal Allergic Rhinitis With Symptoms Aggravated in Presence of Pollutants

Primary Objectives:

• To demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the presence of pollutants is observed using an Environmental Exposure Unit.
• To evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust particulates.

Secondary Objective:

To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.

Study Overview

• Status: Completed
• Conditions: Rhinitis Seasonal
• Intervention / Treatment: Drug: Fexofenadine M016455; Drug: Placebo

Detailed Description

The total study duration per subject is expected to last up to 4.5 months, depending on the timing of the screening visit.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Canada, Canada
    • Investigational Site Number

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Males or females between the ages of 18 and 65 suffering from seasonal allergic rhinitis provoked by ragweed pollen.
• Having a 2-year history of seasonal allergic rhinitis with positive skin prick test to ragweed allergen at screening with a wheal diameter at least 3 mm larger than that produced by the negative control.
• Subjects with antecedents of allergic seasonal allergic rhinitis symptom aggravation when exposed to pollen and air pollutants (i.e., cleaning products, diesel, paints).
• Subjects having a total nasal symptom score ≥3 in Period 1 (Visit 2).

Exclusion criteria:

• History of anaphylaxis to ragweed pollen.
• History of asthma. Mild asthmatics treated only with pro re nata short-acting beta2-agonists, 2 doses or less per week can be enrolled.
• History of chronic sinusitis.
• History of systemic disease affecting the immune system.
• Evidence of any active or suspected bacterial, viral, fungal or parasitic infections within 30 days prior to allergen challenge.
• Any history of Grade 4 anaphylaxis due to any cause as defined by the Common Terminology Criteria for Adverse Event grading criteria ("Life threatening consequences: urgent intervention indicated").
• Presence or history of drug hypersensitivity to fexofenadine.
• Subjects receiving build-up injections of pollen allergen immunotherapy (those on stable maintenance dosing can be included).
• Subjects taking any forbidden treatments/nutriments.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fexofenadine; Fexofenadine, single administration	Drug: Fexofenadine M016455; Pharmaceutical form: tablet Route of administration: oral
Placebo Comparator: Placebo; Placebo, single administration	Drug: Placebo; Pharmaceutical form: tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total nasal symptom score (TNSS)	Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2	From hour 0 to hour 12 in Period 1 and Period 2
TNSS	Assessed by measuring change in the AUC of the TNSS from hour 2 (planned time of investigational medicinal product administration) to hour 12 in Period 3	From hour 2 to hour 12 in Period 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total symptom score (TSS)	Assessed by measuring change in the AUC of TSS from hour 2 (planned time of investigational medicinal product administration) to hour 12	From hour 2 to hour 12 in Period 3
Individual symptom score	Assessed by measuring the change in AUC of individual symptom score from hour 2 (planned time of investigational medicinal product administration) to hour 12	From hour 2 to hour 12 in Period 3
TNSS	Assessed by change in TNSS by time point from hour 2 to hour 12	From hour 2 to hour 12 in Period 3
Adverse events	Incidence of adverse events	Up to 4.5 months

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): January 3, 2019
• Study Completion (Actual): January 3, 2019

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Fexofenadine
• Other Study ID Numbers: LPS15332; U1111-1205-1504 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No