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)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Rhinitis Allergic

Treatments: Drug: triamcinolone XRG5029; Drug: fluticasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03317015

U1111-1178-4882 (Other Identifier)

TRICAL07830

Details and patient eligibility

About

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).

Full description

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

Enrollment: 260 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Group A - Nasacort®

Experimental group

Description:

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

Treatment:

Drug: triamcinolone XRG5029

Group B - Flixonase®

Active Comparator group

Description:

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

Treatment:

Drug: fluticasone