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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Rhinitis Seasonal

Treatments: Drug: Fexofenadine M016455; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03664882

U1111-1205-1504 (Other Identifier)

LPS15332

Details and patient eligibility

About

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.

Full description

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

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Fexofenadine

Experimental group

Description:

Fexofenadine, single administration

Treatment:

Drug: Fexofenadine M016455

Placebo

Placebo Comparator group

Description:

Placebo, single administration

Treatment:

Drug: Placebo