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

NCT ID: NCT03664882

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2019-01-03

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.

Conditions

Rhinitis Seasonal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fexofenadine

Fexofenadine, single administration

Group Type: EXPERIMENTAL

Fexofenadine M016455

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Placebo

Placebo, single administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Interventions

Fexofenadine M016455

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

Placebo

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number

Canada, , Canada

Countries

Canada

Other Identifiers

U1111-1205-1504

Identifier Type: OTHER

Identifier Source: secondary_id

LPS15332

Identifier Type: -

Identifier Source: org_study_id