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

Phase 3

Completed

• Conditions: Rhinitis Seasonal
• Interventions: Drug: Fexofenadine M016455; Drug: Placebo

• Registration Number: NCT03664882
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Study Start: 2018-09-17
• Primary Completion: 2019-01-03
• Study Completion: 2019-01-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fexofenadine	Fexofenadine M016455	Fexofenadine, single administration
Placebo	Placebo	Placebo, single administration

Primary Outcome Measures

Name	Time	Method
Total nasal symptom score (TNSS)	From hour 0 to hour 12 in Period 1 and Period 2	Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2
TNSS	From hour 2 to hour 12 in Period 3	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

Secondary Outcome Measures

Name	Time	Method
Total symptom score (TSS)	From hour 2 to hour 12 in Period 3	Assessed by measuring change in the AUC of TSS from hour 2 (planned time of investigational medicinal product administration) to hour 12
Individual symptom score	From hour 2 to hour 12 in Period 3	Assessed by measuring the change in AUC of individual symptom score from hour 2 (planned time of investigational medicinal product administration) to hour 12
TNSS	From hour 2 to hour 12 in Period 3	Assessed by change in TNSS by time point from hour 2 to hour 12
Adverse events	Up to 4.5 months	Incidence of adverse events

Trial Locations

Locations (1)

Investigational Site Number; 🇨🇦 Canada, Canada