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

April 21, 2022 updated by: Sanofi

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Canada, Canada
        • Investigational Site Number

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total nasal symptom score (TNSS)
Time Frame: From hour 0 to hour 12 in Period 1 and Period 2
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
Time Frame: From hour 2 to hour 12 in Period 3
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total symptom score (TSS)
Time Frame: From hour 2 to hour 12 in Period 3
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
Time Frame: From hour 2 to hour 12 in Period 3
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
Time Frame: From hour 2 to hour 12 in Period 3
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
Time Frame: Up to 4.5 months
Incidence of adverse events
Up to 4.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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