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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

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

Other trials in India

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.

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 groups in NCT05720455
Study groupRoleWhat they receive
Fexofenadine HCL + pseudoephedrine HCLExperimentalParticipants 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.

  1. 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

  2. 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)

  1. 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

  2. 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.

  1. First posted9 Feb 2023
  2. Study start15 Jun 2025
  3. Primary completion5 Dec 2025
  4. Study completion5 Dec 2025

Resources

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)
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

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