Rhinitis SeasonalPhase 3FEXPOLSARNCT03664882
Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants
A Phase 3 study testing Fexofenadine M016455 in people with Rhinitis Seasonal, run by Sanofi at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis Seasonal
- What is being tested?
- Fexofenadine M016455
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2018to 3 Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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").
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3, Single-center, Sequential and Parallel-group, Double-blind, Randomized Study Evaluating the Efficacy and Safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) Versus Placebo in Subjects Suffering From Seasonal Allergic Rhinitis With Symptoms Aggravated in Presence of Pollutants
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.
Read the 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.
- Conditions
- Rhinitis Seasonal
- Being tested
- Fexofenadine M016455, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexofenadine M016455Drug
Pharmaceutical form: tablet Route of administration: oral
PlaceboDrug
Pharmaceutical form: tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Fexofenadine | Experimental | Fexofenadine, single administration Receives: Drug: Fexofenadine M016455 |
| Placebo | Placebo comparator | Placebo, single administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptom score (TNSS)
Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2
Measured: 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
Measured: From hour 2 to hour 12 in Period 3
Secondary outcomes (4)
Total symptom score (TSS)
Assessed by measuring change in the AUC of TSS from hour 2 (planned time of investigational medicinal product administration) to hour 12
Measured: From hour 2 to hour 12 in Period 3
Individual symptom score
Assessed by measuring the change in AUC of individual symptom score from hour 2 (planned time of investigational medicinal product administration) to hour 12
Measured: From hour 2 to hour 12 in Period 3
TNSS
Assessed by change in TNSS by time point from hour 2 to hour 12
Measured: From hour 2 to hour 12 in Period 3
Adverse events
Incidence of adverse events
Measured: Up to 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start17 Sep 2018
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis SeasonalStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664882
- Sponsor's protocol ID
- LPS15332
- Other IDs
- U1111-1205-1504
- Acronym
- FEXPOLSAR
- Status last verified
- Apr 2022
- First submitted
- 7 Sep 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Single-center, Sequential and Parallel-group, Double-blind, Randomized Study Evaluating the Efficacy and Safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) Versus Placebo in Subjects Suffering From Seasonal Allergic Rhinitis With Symptoms Aggravated in Presence of Pollutants
- ClinicalTrials.gov ID
- NCT03664882
- Acronym / sponsor ID
- FEXPOLSAR / LPS15332
- Conditions
- Rhinitis Seasonal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fexofenadine | Experimental | Drug: Fexofenadine M016455Fexofenadine, single administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, single administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Fexofenadine M016455Pharmaceutical form: tablet Route of administration: oral | Drug | Fexofenadine |
| PlaceboPharmaceutical form: tablet Route of administration: oral | Drug | Placebo |
Primary outcome
Total nasal symptom score (TNSS)
Time frame: 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
Time frame: 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
4 secondary outcomes
Total symptom score (TSS)
Time frame: From hour 2 to hour 12 in Period 3
Individual symptom score
Time frame: From hour 2 to hour 12 in Period 3
TNSS
Time frame: From hour 2 to hour 12 in Period 3
Adverse events
Time frame: Up to 4.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- 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 M016455 in people with Rhinitis Seasonal, run by Sanofi 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 4 inclusion and 10 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 25 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total nasal symptom score (TNSS) (time frame: From hour 0 to hour 12 in Period 1 and Period 2). The study lists 2 primary outcomes in all. 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 25 Apr 2022.