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)

Last updated: April 22, 2022
Sponsor: Sanofi
Overall Status: Completed

Phase

3

Condition

Common Cold

Rhinitis, Allergic, Perennial

Allergy

Treatment

N/A

Clinical Study ID

NCT03317015
TRICAL07830
U1111-1178-4882
  • Ages 18-50
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Females and males ≥18 and ≤50 years old.
  • Patients with previously diagnosed PAR with a positive skin prick test response to anappropriate allergen performed not earlier than 12 months prior to the Screeningvisit.
  • Patients must be clinically symptomatic (rTNSS reflecting symptoms for the previous 24h ≥8 with two or more symptoms rated as moderate or severe).
  • Negative urine pregnancy test during screening before first dose of study medicationis 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

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 atleast a 14-day washout prior to the Screening Visit, or viral upper respiratoryinfection 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 deviationthat interferes with nasal airflow.
  • Recent (in the last 3 months) or unhealed nasal septum ulcers, nasal surgery, or nasaltrauma.
  • 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 dermatologicalcorticosteroid within 8 weeks prior to Visit 1;
  • Cromones within 2 weeks prior to Visit 1;
  • Short-acting antihistamines, including antihistamines contained in insomniaformulations 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 etcinfection.
  • Patients suffering from bronchial asthma.
  • Patients suffering from chronic sinusitis.
  • In case of non-allergic rhinitis, nasal trauma or other condition that during thestudy can interfere with symptoms evaluation, subject would be excluded from thestudy.
  • Patients with physical impairment that would affect subject's ability to participatesafely and fully in the study.
  • Clinical evidence of a Candida infection of the nose.
  • History of psychiatric disease, intellectual deficiency, poor motivation, substanceabuse (including drug and alcohol) or other conditions that will limit the validity ofinformed 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'spotential participation in a clinical trial.

Study Design

Total Participants: 260
Study Start date:
November 30, 2016
Estimated Completion Date:
July 10, 2017

Study Description

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