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

NCT05720455 | Completed Phase 4

• 2 other identifiers: LPS17348U1111-1277-6766
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 11

Brief 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. 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).

Conditions

Rhinitis Allergic

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1 to Day 16

Secondary Outcomes (2)

• Mean change from baseline in Total Symptom Score (TSS)

  Day 1, Day 13

• Mean change from baseline in Nasal Congestion Score (NCS)

  Day 1, Day 13

Study Arms (1)

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)

Drug: Fexofenadine HCL and pseudoephedrine HCL

Interventions

Fexofenadine HCL and pseudoephedrine HCL DRUG

Extended-Release Tablets

Also known as: ALLEGRA® D

Fexofenadine HCL + pseudoephedrine HCL

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• i) 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:
• i) 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)

You may not qualify if:

• 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:
• a) 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (11)

Misha ENT Hospital

Ahmedabad, Gujarat, 380008, India

Location

Silver Touch Multispecialty Hospital

Ahmedabad, Gujarat, 380015, India

Location

Pt B.D. Sharma, PGIMS

Rohtak, Haryana, 124001, India

Location

Dr BR Ambedkar Medical College & Hospital

Bangalore, Karnataka, 560045, India

Location

Belagavi Institute of Medical science

Belagavi, Karnataka, 590001, India

Location

Sahyadri super speciality hospital

Pune, Maharashtra, 411004, India

Location

Sum Ultimate Medicare

Bhubaneshwar, Odisha, 751003, India

Location

Apex Hospital Private Limited

Jaipur, Rajasthan, 302017, India

Location

Moti Lal Nehru Medical College

Allahābād, Uttar Pradesh, 211002, India

Location

Swami Rama Himalayan University

Dehradun, Uttarakhand, 248140, India

Location

Nil Ratan Sircar Medical College

Kolkata, West Bengal, 700014, India

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

fexofenadine; Pseudoephedrine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: June 15, 2025
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IN (11)