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

Rhinitis Seasonal Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664882
• Other study ID #: LPS15332
• Secondary ID: U1111-1205-1504
• Status: Completed
• Phase: Phase 3
• Start date: September 17, 2018
• Est. completion date: January 3, 2019

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 3, 2019
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis Seasonal
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Fexofenadine M016455
Pharmaceutical form: tablet Route of administration: oral
• Placebo
Pharmaceutical form: tablet Route of administration: oral

Locations

Country	Name	City	State
Canada	Investigational Site Number	Canada

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	TNSS	Assessed by change in TNSS by time point from hour 2 to hour 12	From hour 2 to hour 12 in Period 3
Secondary	Adverse events	Incidence of adverse events	Up to 4.5 months