A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR) (NASANIF)

A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Prospective Non-inferiority Clinical Trial to Assess Efficacy and Safety of Nasacort® Nasal Spray (Triamcinolone, 55µg) in Comparison With Flixonase® Nasal Spray (Fluticasone, 50 µg) in Adults Suffering From PAR (Perennial Allergic Rhinitis) Administered Once a Day for 28 Days

Primary Objective:

• To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic rhinitis).

Secondary Objectives:

• To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with Flixonase® (fluticasone) administered for 28 days by assessment of adverse events reports.
• To evaluate patient and physician satisfaction after 28 days of treatment by 5-point scale.
• To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ).

Study Overview

• Status: Completed
• Conditions: Rhinitis Allergic
• Intervention / Treatment: Drug: triamcinolone XRG5029; Drug: fluticasone

Detailed Description

The total study duration per patient will be up to approximately 33 days.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Females and males ≥18 and ≤50 years old.
• Patients with previously diagnosed PAR with a positive skin prick test response to an appropriate allergen performed not earlier than 12 months prior to the Screening visit.
• Patients must be clinically symptomatic (rTNSS reflecting symptoms for the previous 24 h ≥8 with two or more symptoms rated as moderate or severe).
• Negative urine pregnancy test during screening before first dose of study medication is administered in women with child-bearing potential.
• Women must use an effective contraceptive method during the study period.
• Patients should be able to understand the study, including risks and adverse events; collaborating with Investigator and proceed according with protocol.
• Signed informed consent form.

Exclusion criteria:

• Compromised ability to provide informed consent.
• Participation in any other clinical study.
• History of severe local reaction(s) or anaphylaxis to skin testing.
• Upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or viral upper respiratory infection within 2 weeks prior to the Screening Visit.
• Subjects who have used any drug (Flixonase or Nasacort) in an investigational protocol 4 weeks prior to the Screening Visit.
• Female subjects who are breast-feeding, pregnant, or intend to become pregnant.
• Patients with nasal abnormalities, including nasal polyps, and marked septum deviation that interferes with nasal airflow.
• Recent (in the last 3 months) or unhealed nasal septum ulcers, nasal surgery, or nasal trauma.
• Specific immunotherapy finished later than 6 months prior to Visit 1.

• Use of following medications:

  • Intranasal corticosteroids within 4 weeks prior to Visit 1;
  • Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid within 8 weeks prior to Visit 1;
  • Cromones within 2 weeks prior to Visit 1;
  • Short-acting antihistamines, including antihistamines contained in insomnia formulations within 3 days prior to Visit 1;
  • Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine;
  • Intranasal antihistamines within 2 weeks prior to Visit 1;
  • Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1;
  • Oral antileukotrienes within 3 days prior to Visit 1;
  • Use of immunosuppressive medications 8 weeks prior to screening.
• Patients allergic to or have sensitivity to the study drug (triamcinolone acetonide, fluticasone propionate) or its excipients.
• Patients suffering from SAR (seasonal allergic rhinitis).
• Patients suffering from non-allergic rhinitis.
• Patients suffering from rhinitis medicamentosa.
• Patients suffering from non-allergic rhinitis caused by viral, bacterial etc infection.
• Patients suffering from bronchial asthma.
• Patients suffering from chronic sinusitis.
• In case of non-allergic rhinitis, nasal trauma or other condition that during the study can interfere with symptoms evaluation, subject would be excluded from the study.
• Patients with physical impairment that would affect subject's ability to participate safely and fully in the study.
• Clinical evidence of a Candida infection of the nose.
• History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would affect the proper daily diary filling.
• Previous history and/or current diagnosis of glaucoma and cataract.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A - Nasacort®; Nasacort® will be sprayed twice in each nostril once every morning	Drug: triamcinolone XRG5029; Pharmaceutical form: spray solution Route of administration: nasal; Other Names: Nasacort®
ACTIVE_COMPARATOR: Group B - Flixonase®; Flixonase® will be sprayed twice in each nostril once every morning	Drug: fluticasone; Pharmaceutical form: spray solution Route of administration: nasal; Other Names: Flixonase®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in total nasal symptom score	From baseline (0 day of treatment) to 28th day of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in quality of life questionnaire scores (miniRQLQ questionnaire)	From baseline (0 day of treatment) to 28th day of treatment
Number of participants with adverse events	From baseline (0 day of treatment) to 28th day of treatment
Assessment of patient satisfaction using the 5-point scale questionnaire	28th day of treatment
Assessment of physician satisfaction using the 5-point scale questionnaire	28th day of treatment

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2016
• Primary Completion (ACTUAL): July 10, 2017
• Study Completion (ACTUAL): July 10, 2017

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (ACTUAL): October 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Triamcinolone; Fluticasone
• Other Study ID Numbers: TRICAL07830; U1111-1178-4882 (OTHER: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No