Rhinitis AllergicPhase 4FASTNCT05720455
Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above
A Phase 4 study testing Fexofenadine HCL and pseudoephedrine HCL in people with Rhinitis Allergic, run by Sanofi at 11 sites in India.
Trial summary
This is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis Allergic
- What is being tested?
- Fexofenadine HCL and pseudoephedrine HCL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 11 sitesIndia
- Study dates
- 15 Jun 2025to 5 Dec 2025
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant (male or female) must be 12 years or more, at the time of signing the informed consent.
- Female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 3 days after the last dose of study intervention
- Male participants who agree to follow the contraceptive guidance during the intervention period and for at least 3 days after the last dose of study intervention
- Capable of giving signed informed consent:
- Signed informed consent (for participants who are 18 years old or above) ii) Participant assent and parental/legal guardian consent (for participants who are less than 18 years old)
Who cannot join
- Participants with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, acute rhinitis, deviation of the nasal septum, etc.), upper respiratory tract infection or acute otitis media that could interfere with judgment of the efficacy of the investigational product (IP) and participants developing cold-like symptoms 30 days before the screening visit
- Participants with severe asthma, bronchiectasis
- Participants using following drugs:
- within 5 days prior to the day of screening: i) Intranasal or oral: antiallergic drugs, decongestants, antihistamines, anticholinergic agents, vasoconstrictor, antihistamine-containing cold remedies, agents that can be expected to have an antiallergic/antihistaminic effect, and other agents that are indicated for allergic symptoms (sneezing, rhinorrhea, nasal congestion, etc.) ii) agents that may affect the blood concentration of fexofenadine (macrolide antibiotics, azole fungicides, and preparations containing aluminum hydroxide / magnesium hydroxide) b) within 2 weeks prior to screening visit: i) participants using steroids, sodium cromoglycate/nedocromil or leukotriene modifiers ii) participants receiving monoamine oxidase (MAO) inhibitor therapy iii) participants receiving immunotherapy or immunosuppressants or nonspecific alternative therapy (histamine containing gamma globulin preparations etc)
- Participants who are participating in another study or who have previously participated in another study within the previous 3 months prior to the day of screening
- Participants were excluded from the study if they had hypersensitivity to, fexofenadine HCL, or pseudoephedrine HCL
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Misha ENT Hospital
Ahmedabad, Gujarat, 380008
Silver Touch Multispecialty Hospital
Ahmedabad, Gujarat, 380015
Moti Lal Nehru Medical College
Allahābād, Uttar Pradesh, 211002
Dr BR Ambedkar Medical College & Hospital
Bangalore, Karnataka, 560045
Belagavi Institute of Medical science
Belagavi, Karnataka, 590001
Sum Ultimate Medicare
Bhubaneswar, Odisha, 751003
Swami Rama Himalayan University
Dehradun, Uttarakhand, 248140
Apex Hospital Private Limited
Jaipur, Rajasthan, 302017
Nil Ratan Sircar Medical College
Kolkata, West Bengal, 700014
Sahyadri super speciality hospital
Pune, Maharashtra, 411004
Pt B.D. Sharma, PGIMS
Rohtak, Haryana, 124001
About this study
Official title: A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)
This is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. The individual study duration for each participant would be approximately 16 days (maximum of 13 days intervention + a 3-day post intervention observation). There would be 4 study visits in which the last visit can be done either telephonically or on site. Safety events would be captured for the entire study duration. In addition, the effectiveness of the study drug would be assessed using Nasal symptom score (NSS) and Total symptom score (TSS).
Read the detailed description
The individual study duration for each participant would be approximately 16 days.
- Conditions
- Rhinitis Allergic
- Being tested
- Fexofenadine HCL and pseudoephedrine HCL
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexofenadine HCL and pseudoephedrine HCLDrug
Also called ALLEGRA® D
Extended-Release Tablets
| Study group | Role | What they receive |
|---|---|---|
| Fexofenadine HCL + pseudoephedrine HCL | Experimental | Participants will take a tablet containing fexofenadine 60 mg and pseudoephedrine 120 mg twice daily for 10 days (+/- 3 days based on investigator's clinical judgement) Receives: Drug: Fexofenadine HCL and pseudoephedrine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
A TEAE is defined as any adverse event (AE) that occur in between the first investigational medicinal product (IMP) administration (on Day 1) and Day 16.
Measured: Day 1 to Day 16
Number of participants with treatment-emergent serious adverse events (SAEs)
A treatment-emergent SAE is defined as any SAE that occur in between the first investigational medicinal product (IMP) administration (on Day 1) and Day 16.
Measured: Day 1 to Day 16
Secondary outcomes (2)
Mean change from baseline in Total Symptom Score (TSS)
The TSS is the sum of physician-assessed nasal symptom scores for sneezing; rhinorrhea; itchy nose, palate, and/or throat; itchy, watery eyes; and nasal congestion, each accessed on 0-4 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms and 4 = very severe symptoms). Higher score indicated more severe symptoms.
Measured: Day 1, Day 13
Mean change from baseline in Nasal Congestion Score (NCS)
Nasal congestion was assessed by the physician on a 0-4 categorical scale, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms and 4 = very severe symptoms. Higher score indicated more severe symptoms.
Measured: Day 1, Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start15 Jun 2025
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis AllergicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 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
- NCT05720455
- Sponsor's protocol ID
- LPS17348
- Other IDs
- U1111-1277-6766
- Acronym
- FAST
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2023
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open Label, Clinical Trial to Assess Safety and Efficacy of Fexofenadine HCL + Pseudoephedrine HCL Fixed Dose Combination in Indian Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (FAST Trial)
- ClinicalTrials.gov ID
- NCT05720455
- Acronym / sponsor ID
- FAST / LPS17348
- Conditions
- Rhinitis Allergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 9 Feb 2023 (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.
This is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. The individual study duration for each participant would be approximately 16 days (maximum of 13 days intervention + a 3-day post intervention observation). There would be 4 study visits in which the last visit can be done either telephonically or on site. Safety events would be captured for the entire study duration. In addition, the effectiveness of the study drug would be assessed using Nasal symptom score (NSS) and Total symptom score (TSS).
Detailed description
The individual study duration for each participant would be approximately 16 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fexofenadine HCL + pseudoephedrine HCL | Experimental | Drug: Fexofenadine HCL and pseudoephedrine HCLParticipants will take a tablet containing fexofenadine 60 mg and pseudoephedrine 120 mg twice daily for 10 days (+/- 3 days based on investigator's clinical judgement) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participant (male or female) must be 12 years or more, at the time of signing the informed consent.
- Female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Male participants who agree to follow the contraceptive guidance during the intervention period and for at least 3 days after the last dose of study intervention
- Capable of giving signed informed consent:
Key exclusion criteria (7 listed)
- Participants with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, acute rhinitis, deviation of the nasal septum, etc.), upper respiratory tract infection or acute otitis media that could interfere with judgment of the efficacy of the investigational product (IP) and participants developing cold-like symptoms 30 days before the screening visit
- Participants with severe asthma, bronchiectasis
- Participants using following drugs:
- Participants who are participating in another study or who have previously participated in another study within the previous 3 months prior to the day of screening
- Participants were excluded from the study if they had hypersensitivity to, fexofenadine HCL, or pseudoephedrine HCL
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 HCL and pseudoephedrine HCLAlso: ALLEGRA® DExtended-Release Tablets | Drug | Fexofenadine HCL + pseudoephedrine HCL |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Day 1 to Day 16
A TEAE is defined as any adverse event (AE) that occur in between the first investigational medicinal product (IMP) administration (on Day 1) and Day 16.
Number of participants with treatment-emergent serious adverse events (SAEs)
Time frame: Day 1 to Day 16
A treatment-emergent SAE is defined as any SAE that occur in between the first investigational medicinal product (IMP) administration (on Day 1) and Day 16.
2 secondary outcomes
Mean change from baseline in Total Symptom Score (TSS)
Time frame: Day 1, Day 13
Mean change from baseline in Nasal Congestion Score (NCS)
Time frame: Day 1, Day 13
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 17 Feb 2026.
- 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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fexofenadine HCL and pseudoephedrine HCL in people with Rhinitis Allergic, run by Sanofi at 11 sites in India.
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 6 inclusion and 7 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Day 1 to Day 16). 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 17 Feb 2026.