Back to resultsStudy Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants (FEXPOLSAR)
Primary Purpose
Rhinitis Seasonal
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Fexofenadine M016455
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis Seasonal
Eligibility 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.
Sites / Locations
- Investigational Site Number
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fexofenadine
Placebo
Arm Description
Fexofenadine, single administration
Placebo, single administration
Outcomes
Primary Outcome Measures
Total nasal symptom score (TNSS)
Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 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
Secondary Outcome Measures
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
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
TNSS
Assessed by change in TNSS by time point from hour 2 to hour 12
Adverse events
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03664882
Brief Title
Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants
Acronym
FEXPOLSAR
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
January 3, 2019 (Actual)
Study Completion Date
January 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis Seasonal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fexofenadine
Arm Type
Experimental
Arm Description
Fexofenadine, single administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, single administration
Intervention Type
Drug
Intervention Name(s)
Fexofenadine M016455
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Total nasal symptom score (TNSS)
Description
Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2
Time Frame
From hour 0 to hour 12 in Period 1 and Period 2
Title
TNSS
Description
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
Time Frame
From hour 2 to hour 12 in Period 3
Secondary Outcome Measure Information:
Title
Total symptom score (TSS)
Description
Assessed by measuring change in the AUC of TSS from hour 2 (planned time of investigational medicinal product administration) to hour 12
Time Frame
From hour 2 to hour 12 in Period 3
Title
Individual symptom score
Description
Assessed by measuring the change in AUC of individual symptom score from hour 2 (planned time of investigational medicinal product administration) to hour 12
Time Frame
From hour 2 to hour 12 in Period 3
Title
TNSS
Description
Assessed by change in TNSS by time point from hour 2 to hour 12
Time Frame
From hour 2 to hour 12 in Period 3
Title
Adverse events
Description
Incidence of adverse events
Time Frame
Up to 4.5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number
City
Canada
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants
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