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

Launched by SANOFI · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a combination medication called Allegra® D, which includes fexofenadine and pseudoephedrine, for people aged 12 and older who have allergic rhinitis, also known as hay fever. Allergic rhinitis causes symptoms like sneezing, runny nose, and nasal congestion due to allergies. The trial will last about 16 days for each participant, which includes 13 days of receiving the medication and a 3-day observation period afterward. Throughout the study, participants will visit the study site four times, and the last visit can be done over the phone if preferred. The researchers will monitor any side effects and measure how well the medication works based on the participants' nasal symptoms.

To be eligible for this trial, participants must be at least 12 years old and either male or female. Female participants should not be pregnant or breastfeeding, and those who can become pregnant must follow specific contraceptive guidelines during the study. Participants should not have any other nasal diseases or recent upper respiratory infections that could affect the study results. People taking certain medications or who have had allergic reactions to the study drug will not be able to join. Overall, this trial aims to help find better treatments for those suffering from allergic rhinitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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.