Clinical trial NCT03664882: Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis Seasonal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-09-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Total nasal symptom score (TNSS)
timeFrame: From hour 0 to hour 12 in Period 1 and Period 2
measure: TNSS
timeFrame: From hour 2 to hour 12 in Period 3
Secondary outcomes:
measure: Total symptom score (TSS)
timeFrame: From hour 2 to hour 12 in Period 3
measure: Individual symptom score
timeFrame: From hour 2 to hour 12 in Period 3
measure: TNSS
timeFrame: From hour 2 to hour 12 in Period 3
measure: Adverse events
timeFrame: Up to 4.5 months
Other outcomes:
Locations:
city: Canada
country: Canada
facility: Investigational Site Number
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: