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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664882
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Rhinitis Seasonal Drug: Fexofenadine M016455 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : January 3, 2019
Actual Study Completion Date : January 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

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




Primary Outcome Measures :
  1. 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

  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


Secondary Outcome Measures :
  1. 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

  2. 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

  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

  4. Adverse events [ Time Frame: Up to 4.5 months ]
    Incidence of adverse events



Information from the National Library of Medicine

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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
Criteria

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.


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): NCT03664882


Locations
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Canada
Investigational Site Number
Canada, Canada
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03664882     History of Changes
Other Study ID Numbers: LPS15332
U1111-1205-1504 ( Other Identifier: UTN )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/

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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

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs