Clinical trial NCT03317015: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis Allergic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-10-23
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in total nasal symptom score
timeFrame: From baseline (0 day of treatment) to 28th day of treatment
Secondary outcomes:
measure: Change from baseline in quality of life questionnaire scores (miniRQLQ questionnaire)
timeFrame: From baseline (0 day of treatment) to 28th day of treatment
measure: Number of participants with adverse events
timeFrame: From baseline (0 day of treatment) to 28th day of treatment
measure: Assessment of patient satisfaction using the 5-point scale questionnaire
timeFrame: 28th day of treatment
measure: Assessment of physician satisfaction using the 5-point scale questionnaire
timeFrame: 28th day of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: