Seasonal Allergic RhinitisPhase 3FEXPRESARNCT05692154
A Placebo-controlled Study of 2-day Pre-treatment With Fexofenadine in Seasonal Allergic Rhinitis
A Phase 3 study testing Fexofenadine in people with Seasonal Allergic Rhinitis, run by Opella Healthcare Group SAS, a Sanofi Company at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Fexofenadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2023to 14 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 seasonal allergic rhinitis (SAR) provoked by Ragweed pollen.
- Participants having a total nasal symptom score (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).
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Fexofenadine, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FexofenadineDrug
Fexofenadine oral tablet
PlaceboDrug
Fexofenadine matching placebo oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm A (active-active) | Experimental | Two days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4. Receives: Drug: Fexofenadine |
| Arm B (placebo-active) | Experimental | Two days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3)
TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC [0-6 hr]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.5; Arm B=2.1-39.9.
Measured: From 0 hour to 6 hours at Day 4
Secondary outcomes (6)
AUC of Total Ocular Symptoms Score (TOSS) (H0-H6 at Day 4)
TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC [0-6 hr]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.6; Arm B=0.0-35.1.
Measured: From 0 hour to 6 hours at Day 4
AUC of Total Nasal Symptoms Score (TNSS-3) (H0-H12 at Day 4)
TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC [0-12 hr]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-63.5; Arm B=2.1-69.4.
Measured: From 0 hour to 12 hours at Day 4
AUC of Total Ocular Symptoms Score (TOSS) (H0-H12 at Day 4)
TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC [0-12 hr]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-58.6; Arm B=0.0-65.5.
Measured: From 0 hour to 12 hours at Day 4
AUC of Total Nasal Symptoms Score (TNSS-3) (Day 1 to Day 4)
TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3:scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC [Day 1 to Day 4]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-267.8; Arm B=2.1-379.0.
Measured: From randomization (Day 1) to Day 4
AUC of Total Ocular Symptoms Score (TOSS) (Day 1 to Day 4)
TOSS=composite score calculated as the sum of red/burning eyes, tearing, itchy/watery eyes scores (TOSS: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. individual scores were collected in e-diary. AUC of TOSS from time of the first observation to time of the last observation (AUC [Day 1 to Day 4]) was calculated by using the linear trapezoid. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-226.6; Arm B=0.0-304.5.
Measured: From randomization (Day 1) to Day 4
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A treatment emergent adverse event (TEAE) is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.
Measured: From Day 2 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start23 Jan 2023
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opella Healthcare Group SAS, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692154
- Sponsor's protocol ID
- LPS17180
- Other IDs
- U1111-1278-3949
- Acronym
- FEXPRESAR
- Status last verified
- Sep 2025
- First submitted
- 11 Jan 2023
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05692154
- Acronym / sponsor ID
- FEXPRESAR / LPS17180
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Opella Healthcare Group SAS, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (active-active) | Experimental | Drug: FexofenadineTwo days of pre-treatment with Fexofenadine 180 mg each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4. |
| Arm B (placebo-active) | Experimental | Drug: PlaceboTwo days of pre-treatment with tablet of matching placebo each day in the morning on Day 2 and Day 3, then Fexofenadine180 mg after the pollen challenge on Day 4. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 seasonal allergic rhinitis (SAR) provoked by Ragweed pollen.
- Participants having a total nasal symptom score (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).
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FexofenadineFexofenadine oral tablet | Drug | Arm A (active-active) |
| PlaceboFexofenadine matching placebo oral tablet | Drug | Arm B (placebo-active) |
Primary outcome
Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3)
Time frame: From 0 hour to 6 hours at Day 4
TNSS-3=composite score calculated as sum of rhinorrhea, sneezing, and nasal itching scores (TNSS-3: scale of each symptom is scored from 0 to 3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. Individual scores were collected in e-diary. AUC of TNSS from time of the first observation to time of the last observation (AUC [0-6 hr]) was calculated by using the linear trapezoid method. Trapezoidal rule involves dividing the area into a number of strips of equal width. Then, approximating the area of each strip by the area of the trapezium formed when a chord replaces upper end. Sum of these approximations gives final numerical result of area under the curve. AUC range: Arm A=0.0-43.5; Arm B=2.1-39.9.
6 secondary outcomes
AUC of Total Ocular Symptoms Score (TOSS) (H0-H6 at Day 4)
Time frame: From 0 hour to 6 hours at Day 4
AUC of Total Nasal Symptoms Score (TNSS-3) (H0-H12 at Day 4)
Time frame: From 0 hour to 12 hours at Day 4
AUC of Total Ocular Symptoms Score (TOSS) (H0-H12 at Day 4)
Time frame: From 0 hour to 12 hours at Day 4
AUC of Total Nasal Symptoms Score (TNSS-3) (Day 1 to Day 4)
Time frame: From randomization (Day 1) to Day 4
AUC of Total Ocular Symptoms Score (TOSS) (Day 1 to Day 4)
Time frame: From randomization (Day 1) to Day 4
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From Day 2 to Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- LPS17180 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fexofenadine in people with Seasonal Allergic Rhinitis, run by Opella Healthcare Group SAS, a Sanofi Company at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under Curve (AUC) of the Total Nasal Symptoms Score (TNSS-3) (time frame: From 0 hour to 6 hours at Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.