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

NCT03664882 | Completed Phase 3

• 2 other identifiers: LPS15332U1111-1205-1504
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis Seasonal

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Total symptom score (TSS)

  From hour 2 to hour 12 in Period 3

• Individual symptom score

  From hour 2 to hour 12 in Period 3

• TNSS

  From hour 2 to hour 12 in Period 3

• Adverse events

  Up to 4.5 months

Study Arms (2)

Fexofenadine

EXPERIMENTAL

Fexofenadine, single administration

Drug: Fexofenadine M016455

Placebo

PLACEBO COMPARATOR

Placebo, single administration

Drug: Placebo

Interventions

Fexofenadine M016455 DRUG

Pharmaceutical form: tablet Route of administration: oral

Fexofenadine

Placebo DRUG

Pharmaceutical form: tablet Route of administration: oral

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number

Canada, Canada

Location

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: September 17, 2018
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)