Perennial Allergic Rhinitis Clinical Trial
Official title:
Prospective, Comparative, Double-blind, Parallel, Multicentric, Randomized Study Between Two Brands of Fluticasone Propionate Nasal Topic in The Control of Perene Allergic Rhinithis Symptoms
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.
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.
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