Topical Nasal Fluticasone Propionate in the Control of Allergic Rhinitis SymptomsPerene
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III Study to Demonstrate the non inferiority of PLURAIR® branded nasal topical
      Fluticasone Propionate (FP) in relation to the FLIXONASE® brand reference drug in the control
      of nasal symptoms related to perennial allergic rhinitis.
    

Detailed description: 
      This study was conducted to demonstrate the non inferiority of the topical nasal fluticasone
      propionate of the brand Plurair® in relation to the reference drug Flixonase® in the control
      of symptoms related to perennial allergic rhinitis. Allergic rhinitis is one of the most
      common forms of non-infectious rhinitis, characterized mainly by symptoms such as sneezing,
      runny nose and nasal congestion. Depending on the time of exposure to allergens and the
      duration of symptoms, allergic rhinitis is classified as perennial (OKUBO, 2009).

      Studies for the assessment of perennial allergic rhinitis through symptom analysis used
      diaries provided to the participants, so that they could describe their symptoms, starting in
      the screening phase and ending at the end of treatment. In the present study, participants
      recorded, in the diary, the severity of their rhinitis symptoms (obstruction, runny nose,
      nasal itching and sneezing) and also associated eye symptoms (watery eyes, itchy eyes and
      redness) using a four-point scale (0-absent, 1-mild, 2-moderate and 3-severe). For the
      purpose of analyzing the primary parameter, the total daily reflective nasal symptoms (NRT)
      was obtained by averaging the total morning and evening scores for each day ([morning NRT +
      night NRT] / 2) of the individual nasal symptoms - obstruction, itching, runny nose and
      sneezing - assessed reflexively in the last 12 hours.

      This study in its design and analysis of efficacy and safety followed the guidelines of
      regulatory agencies in the United States of America (FDA, 2000) and Canada (CANADA HEALTH,
      2011).

      Fluticasone propionate is a potent intranasal corticosteroid with negligible bioavailability,
      effective in the treatment of nasal symptoms of allergic rhinitis. The onset of the
      therapeutic effect of fluticasone propionate occurs within 12 hours when 200 μg of the
      medication is administered once a day (RATNER, 2008).

      Following guidelines for the use of fluticasone propionate and guidelines for the assessment
      of symptoms of perennial allergic rhinitis, the objective of the present clinical study was
      to evaluate the efficacy and safety of two formulations of fluticasone propionate as a single
      agent in the treatment of perennial allergic rhinitis through relief of nasal symptoms
      assessed by recording in the participants' symptom diary.

      This study was conducted in accordance with the proposal for the treatment of perennial
      allergic rhinitis, with local clinical research regulations, with the International
      Harmonization Conference (ICH) Good Clinical Practices and with the principles of the
      Declaration Helsinki and their respective revisions.
    

Intervention name(s): Fluticasone Propionate
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase III, prospective, comparative, double-blind, parallel, multicenter, randomized, non-inferiority clinical study between two brands of nasal topical fluticasone propionate:
Plurair® - Experimental medicine.
Flixonase® - Comparator. Study treatment was allocated by centralized randomization, and each participant remained on the same treatment (dose, dosing regimen and brand) allocated throughout the study period.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Plurair; Fluoticasone propionate; topic; nasal