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

A Phase IIIb, Single-center, Double-blind, Two-arms, Placebo-controlled, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of 2-day Pre-treatment With Fexofenadine in Patients Suffering From Seasonal Allergic Rhinitis

This study is a proof-of-concept study to demonstrate if a daily dose of a 2-days pre-treatment of Fexofenadine 180mg is effective in alleviating the AR symptoms and to assess the additional benefit to the patient in terms of preventing Allergic Rhinitis (AR) symptoms.

The total study duration per participant is expected at least 4 months, depending on the timing of the screening visit. 5 visits are planned, screening, confirmation inclusion challenge, randomization visit, challenge and end of study visit.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Fexofenadine; Drug: Placebo

Detailed Description

The end of the study is defined as the date of the last visit of the last participant in the study.

A participant is considered to have completed the study if he/she has completed all visits of the study including Visit 5 (Day 5).

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Investigational Site Number : 1240001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Participant is willing to provide written informed consent.
• Adult participants (18 to 80 years old) suffering from SAR provoked by Ragweed pollen.
• Participants having a TNSS-3 ≥4 (with 3 nasal symptoms) at first pollen challenge at Visit 2.
• Having a 2-year history of SAR 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).

Exclusion Criteria:

• History of anaphylaxis to Ragweed pollen History of asthma or exacerbations in the past 12 months requiring regular inhaled corticosteroids for greater than 4 weeks per year, any oral corticosteroid usage, any emergency department visit for asthma or any asthma-related hospitalization. Mild asthmatics treated only with pro re nata short-acting β2agonists, less than 2 doses per week can be enrolled.
• History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
• History of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease, or immunodeficiency, where, in the opinion of the study physician, participation in the trial would pose a risk or significant effect on the immune system.
• Presence or history of drug hypersensitivity to fexofenadine and/or its excipients.

• Participants unable to stop the following forbidden treatments/nutriments prior to pollen challenge:

  • Antihistamines: within 3 days for first-generation antihistamines, within 2 days for second-generation antihistamines.
  • Intranasal or inhaled corticosteroids: 7 days.
  • Ocular, intranasal, or inhaled sodium cromoglycate: 14 days.
  • High doses of systemic corticosteroids: 30 days.
  • Leukotriene antagonists: 30 days.
  • Intranasal or systemic decongestants: 3 days.
  • Tricyclic antidepressants: 7 days.
  • Any citrus fruits (grapefruit, orange, etc.) or their juices, as well as all fruit juices: 5 days.
  • Aluminum-and-magnesium containing antacids: 7 days.
  • Omalizumab/dupilumab: within 6 months
• Any contraindications to fexofenadine, according to the labeling.
• The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (active-active); Two days of pre-treatment with Fexofenadine, then Fexofenadine180 mg during the test pollen challenge.	Drug: Fexofenadine; Fexofenadine oral tablet
Experimental: Arm B (placebo-active); Two days of pre-treatment with Placebo, then Fexofenadine180 during the test pollen challenge.	Drug: Placebo; Fexofenadine matching placebo oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of the total nasal symptoms score (TNSS-3)	Area under the plasma concentration-time curve (AUC) of TNSS-3 The total nasal symptom score of 3 symptoms (TNSS-3: scale of each symptom is scored from 0 to 3): rhinorrhea, sneezing, and nasal itching scores.	from 0 hour to 6 hours at day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of total ocular symptoms score (TOSS) (0h-6h at day 4)	TOSS = Total Ocular Symptoms Score.	from 0 hour to 6 hours at day 4
AUC of total nasal symptoms score (TNSS-3) (0h-12h at day 4)		from 0 hour to 12 hours at day 4
AUC of total ocular symptoms score (TOSS) (0h-12h at day 4)		from 0 hour to 12 hours at day 4
AUC of total nasal symptoms score (TNSS-3) (Day 1 to day 4)		from randomization (day 1 ) to day 4
AUC of total ocular symptoms score (TOSS) (Day 1 to day 4)		from randomization (day 1) to day 4
Percentage of participants with Adverse Events		from screening to day 5

Collaborators and Investigators

• Sponsor: Opella Healthcare Group SAS, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): March 14, 2023
• Study Completion (Actual): March 14, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Fexofenadine
• Other Study ID Numbers: LPS17180; U1111-1278-3949 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes