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)

NCT03317015 | Completed Phase 3

• 2 other identifiers: TRICAL07830U1111-1178-4882
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Rhinitis Allergic

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total nasal symptom score

  From baseline (0 day of treatment) to 28th day of treatment

Secondary Outcomes (4)

• 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

Study Arms (2)

Group A - Nasacort®

EXPERIMENTAL

Nasacort® will be sprayed twice in each nostril once every morning

Drug: triamcinolone XRG5029

Group B - Flixonase®

ACTIVE COMPARATOR

Flixonase® will be sprayed twice in each nostril once every morning

Drug: fluticasone

Interventions

triamcinolone XRG5029 DRUG

Pharmaceutical form: spray solution Route of administration: nasal

Also known as: Nasacort®

Group A - Nasacort®

fluticasone DRUG

Pharmaceutical form: spray solution Route of administration: nasal

Also known as: Flixonase®

Group B - Flixonase®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Triamcinolone; Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Androstadienes; Androstenes; Androstanes

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: November 30, 2016
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share