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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

  • NCT ID: NCT05720455
  • Time Stamp: July 20, 2024
  • Source Node: 133966
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Email: Contact-US@sanofi.com
  • Phone: 800-633-1610
  • 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).

Studies

Study First Submitted Date 2023-01-31
Study First Posted Date 2023-02-09
Last Update Posted Date 2023-07-28
Start Month Year July 21, 2024
Primary Completion Month Year February 7, 2025
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-28

Detailed Descriptions

Sequence: 20849308
Description The individual study duration for each participant would be approximately 16 days.

Browse Interventions

Sequence: 96583077 Sequence: 96583078 Sequence: 96583079 Sequence: 96583080 Sequence: 96583081 Sequence: 96583082 Sequence: 96583083 Sequence: 96583084 Sequence: 96583085 Sequence: 96583086 Sequence: 96583087 Sequence: 96583088 Sequence: 96583089 Sequence: 96583090 Sequence: 96583091 Sequence: 96583092 Sequence: 96583093 Sequence: 96583094 Sequence: 96583095 Sequence: 96583096 Sequence: 96583097
Mesh Term Fexofenadine Mesh Term Pseudoephedrine Mesh Term Ephedrine Mesh Term Bronchodilator Agents Mesh Term Autonomic Agents Mesh Term Peripheral Nervous System Agents Mesh Term Physiological Effects of Drugs Mesh Term Anti-Asthmatic Agents Mesh Term Respiratory System Agents Mesh Term Nasal Decongestants Mesh Term Vasoconstrictor Agents Mesh Term Central Nervous System Stimulants Mesh Term Sympathomimetics Mesh Term Adrenergic Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Anti-Allergic Agents Mesh Term Histamine H1 Antagonists, Non-Sedating Mesh Term Histamine H1 Antagonists Mesh Term Histamine Antagonists Mesh Term Histamine Agents
Downcase Mesh Term fexofenadine Downcase Mesh Term pseudoephedrine Downcase Mesh Term ephedrine Downcase Mesh Term bronchodilator agents Downcase Mesh Term autonomic agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term physiological effects of drugs Downcase Mesh Term anti-asthmatic agents Downcase Mesh Term respiratory system agents Downcase Mesh Term nasal decongestants Downcase Mesh Term vasoconstrictor agents Downcase Mesh Term central nervous system stimulants Downcase Mesh Term sympathomimetics Downcase Mesh Term adrenergic agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term anti-allergic agents Downcase Mesh Term histamine h1 antagonists, non-sedating Downcase Mesh Term histamine h1 antagonists Downcase Mesh Term histamine antagonists Downcase Mesh Term histamine agents
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52499437
Name Rhinitis Allergic
Downcase Name rhinitis allergic

Id Information

Sequence: 40393325 Sequence: 40393326
Id Source org_study_id Id Source secondary_id
Id Value LPS17348 Id Value U1111-1277-6766
Id Type Registry Identifier
Id Type Description ICTRP

Design Groups

Sequence: 55955494
Group Type Experimental
Title Fexofenadine HCL + pseudoephedrine HCL
Description 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)

Interventions

Sequence: 52807568
Intervention Type Drug
Name Fexofenadine HCL and pseudoephedrine HCL
Description Extended-Release Tablets

Design Outcomes

Sequence: 178604799 Sequence: 178604800 Sequence: 178604801 Sequence: 178604802
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Number of participants with treatment-emergent adverse events (TEAEs) Measure Number of participants with treatment-emergent serious adverse events (SAEs) Measure Mean change from baseline in Total Symptom Score (TSS) Measure Mean change from baseline in Nasal Congestion Score (NCS)
Time Frame Day 1 to Day 16 Time Frame Day 1 to Day 16 Time Frame Day 1, Day 13 Time Frame Day 1, Day 13
Description 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. Description 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. Description 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. Description 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.

Browse Conditions

Sequence: 194739001 Sequence: 194739002 Sequence: 194739003 Sequence: 194739004 Sequence: 194739005 Sequence: 194739006 Sequence: 194739007 Sequence: 194739008 Sequence: 194739009 Sequence: 194739010 Sequence: 194739011
Mesh Term Rhinitis Mesh Term Rhinitis, Allergic Mesh Term Respiratory Tract Infections Mesh Term Infections Mesh Term Nose Diseases Mesh Term Respiratory Tract Diseases Mesh Term Otorhinolaryngologic Diseases Mesh Term Respiratory Hypersensitivity Mesh Term Hypersensitivity, Immediate Mesh Term Hypersensitivity Mesh Term Immune System Diseases
Downcase Mesh Term rhinitis Downcase Mesh Term rhinitis, allergic Downcase Mesh Term respiratory tract infections Downcase Mesh Term infections Downcase Mesh Term nose diseases Downcase Mesh Term respiratory tract diseases Downcase Mesh Term otorhinolaryngologic diseases Downcase Mesh Term respiratory hypersensitivity Downcase Mesh Term hypersensitivity, immediate Downcase Mesh Term hypersensitivity Downcase Mesh Term immune system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48623517
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Sanofi

Overall Officials

Sequence: 29456693
Role Study Director
Name Clinical Sciences & Operations
Affiliation Sanofi

Central Contacts

Sequence: 12093533
Contact Type primary
Name Trial Transparency email recommended (Toll free for US & Canada)
Phone 800-633-1610
Email Contact-US@sanofi.com
Phone Extension option 6
Role Contact

Design Group Interventions

Sequence: 68596359
Design Group Id 55955494
Intervention Id 52807568

Eligibilities

Sequence: 30952711
Gender All
Minimum Age 12 Years
Maximum Age N/A
Healthy Volunteers No
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.
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 253874636
Registered In Calendar Year 2023
Were Results Reported False
Has Single Facility False
Minimum Age Num 12
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30698295
Allocation Non-Randomized
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26836615
Intervention Id 52807568
Name ALLEGRA® D

Responsible Parties

Sequence: 29065055
Responsible Party Type Sponsor
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