NCT04332978

Topical Nasal Fluticasone Propionate in the Control of Allergic Rhinitis SymptomsPerene

Prospective, Comparative, Double-blind, Parallel, Multicentric, Randomized Study Between Two Brands of Fluticasone Propionate Nasal Topic in The Control of Perene Allergic Rhinithis Symptoms

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 566 (actual)
• Sponsor: Libbs Farmacêutica LTDA · Industry
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate

Timeline

• Start date: 2014-07-04
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2020-04-03
• Last updated: 2020-04-08