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Antihistamine

Fexofenadine for Seasonal Allergic Rhinitis (FEXPRESAR Trial)

Phase 3

Waitlist Available

Research Sponsored by Opella Healthcare Group SAS, a Sanofi Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 0 hour to 12 hours at day 4

Awards & highlights

FEXPRESAR Trial Summary

This trial tests if a daily dose of a 2-day pre-treatment of Fexofenadine 180mg can help prevent Allergic Rhinitis symptoms. 5 visits planned, taking at least 4 months.

Eligible Conditions

Hay Fever

FEXPRESAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 0 hour to 12 hours at day 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 0 hour to 12 hours at day 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 hour to 12 hours at day 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC of the total nasal symptoms score (TNSS-3)

Secondary outcome measures

AUC of total nasal symptoms score (TNSS-3) (0h-12h at day 4)

AUC of total nasal symptoms score (TNSS-3) (Day 1 to day 4)

AUC of total ocular symptoms score (TOSS) (0h-12h at day 4)

+3 more

FEXPRESAR Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (placebo-active)Experimental Treatment1 Intervention

Two days of pre-treatment with Placebo, then Fexofenadine180 during the test pollen challenge.

Group II: Arm A (active-active)Experimental Treatment1 Intervention

Two days of pre-treatment with Fexofenadine, then Fexofenadine180 mg during the test pollen challenge.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fexofenadine

2016

Completed Phase 4

~940

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Opella Healthcare Group SAS, a Sanofi CompanyLead Sponsor

3 Previous Clinical Trials

137 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,744 Total Patients Enrolled

Media Library

Fexofenadine (Antihistamine) Clinical Trial Eligibility Overview. Trial Name: NCT05692154 — Phase 3

Hay Fever Research Study Groups: Arm A (active-active), Arm B (placebo-active)

Hay Fever Clinical Trial 2023: Fexofenadine Highlights & Side Effects. Trial Name: NCT05692154 — Phase 3

Fexofenadine (Antihistamine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05692154 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this experiment limited to individuals under 45 or can those aged forty-five and above still participate?

"Those between the age of majority and octogenarianism are eligible to be enrolled in this medical investigation."

Answered by AI

Is recruitment for this experiment currently underway?

"According to records on clinicaltrials.gov, this medical trial still seeks participants. The study was first advertised on January 23rd 2023 and its data was updated as recently as the 29th of that same month."

Answered by AI

Does the Arm A (active-active) regimen pose any hazards for medical participants?

"Our team at Power was assured by the data collected in Phase 3 trials that Arm A (active-active) is safe and gave it a score of 3."

Answered by AI

Who is the ideal candidate to join this clinical trial?

"This investigation seeks 96 people with hay fever aged 18 to 80. To qualify, volunteers must provide written consent and verify three nasals symptoms on TNSS-3 scale at visit two in addition to a positive skin prick test result for Ragweed allergen during the screening period (wheal diameter must be greater than that of negative control)."

Answered by AI

How many individuals are involved in this experiment?

"Affirmative. Clinicaltrials.gov reports that this research is in the process of recruiting participants, having been published on January 23rd 2023 and updated lastly on the 29th of January 2023. The study requires 96 volunteers from a single site to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis

2023. "A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05692154.