Topical Nasal Fluticasone Propionate in the Control of Allergic Rhinitis SymptomsPerene

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Libbs Farmacêutica LTDA
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Men and women aged ≥ 12 years and <60 years old on the date of the selection visit;

• Clinical history suggestive of perennial allergic rhinitis for at least 02 years;

• Atopy proved through positive evaluation for at least one inhaled allergen (valid positive RAST test performed up to 12 months before the date of the selection visit - or positive Phadiatop® ** performed during the selection period);

• Present the score for reflective nasal symptoms (runny nose, nasal itching, nasal obstruction and sneezing) equal to or greater than the average of 12 points out of a total of 24, during the 4 days preceding the randomization visit OR Present a score of reflective nasal symptoms (runny nose, itchy nose, nasal obstruction and sneezing) at least 12, for at least 4 days, not necessarily consecutive, within a seven-day selection period;

• "Research participant's diary - selection" correctly filled out, considering at least 80% of the completed information regarding nasal and ocular symptoms in the two periods (morning and night);

• Availability of telephone contact for follow-up;

• Signature of the Free and Informed Consent Term and Free and Informed Consent Term, when applicable.

Exclusion Criteria:

• Pregnancy or lactation;

• Women who declare that they have the potential to become pregnant and do not want to adopt any contraceptive method, including: sexual abstinence, mechanical barrier, IUD, oral contraceptive, injectable contraceptive, hormonal implant, hormonal transdermal patch, prior sterilization, etc;

• Other clinical forms of rhinitis: seasonal allergic, medication, vasomotor, atrophic, etc;

• History compatible with IVAS or acute sinusitis in the 15 days prior to the selection visit, symptomatic chronic sinusitis, nasal polyposis;

• Concomitant cardiovascular / hepatic / pulmonary / renal / neurological / neoplastic disease and others, which medical criteria may compromise the patient's participation in the study;

• Current smoking or previous smoking for less than 3 months;

• Cataract, glaucoma, herpes simplex ocular;

• Asthma, with the exception of controlled conditions (GINA Criteria - Global Initiative for Asthma - modified: absence of daytime symptoms, nighttime despair and experiences in experimental activities) without the need for specific medication;

• Previous use of:

• Antihistamine for less than 10 days with the exception of azelastine / astemizole for less than 12 weeks.

• Topical, intranasal and systemic corticosteroids for less than 4 weeks;

• Antileukotriene / anticholinergic / antifungal / antibiotics less than 7 days ago

• Intranasal or systemic decongestant for less than 03 days;

• Non-hormonal anti-inflammatory, including acetylsalicylic acid with use in less than 10 days;

• Use of drugs with the potential to alter cytochrome P450 (eg, ritonavir and ketoconazole, but not exclusively) or with possible clinical influence (eg, tricyclic antidepressants, but not exclusively) or with nasal administration (eg, insulin, but not exclusively);

• History of nasosinusal surgery;

• Results of laboratory selection tests with significant clinical changes (complete blood count, TGO / AST, TGP / ALT, salt, potassium, urea, creatinine, fasting glucose and serum cortisol), which a doctor may compromise the patient's participation in. study;

• Serious illness or condition that the doctor may compromise the patient's participation in the study.