Topical Nasal Fluticasone Propionate in the Control of Allergic Rhinitis SymptomsPerene

NCT04332978 | Completed Phase 3

• 1 other identifier: LB1108
• Study Type: interventional
• Target: 566
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perennial Allergic Rhinitis

Keywords

Plurair; Fluoticasone propionate; topic; nasal

Outcome Measures

Primary Outcomes (1)

• Variation of the mean of total reflective nasal symptoms (TSNr)

  Patients should be instructed to classify and note the severity of nasal symptoms (itching, sneezing, obstruction and coryza) using the "Research participant's diary", the reflexive way in the last 12 hours, with an assessment in the morning and another at night (twice a day, regardless of specified times), with a 4-point scale below: 0: ABSENT - this symptom is not present. 1. Mild - this symptom is present, but does not bother. 2. MODERATE - this symptom is present and is substantially received, but it does not get in the way of your daily activities / sleep quality. 3. SEVERE - this symptom is present, enters substantially and gets in the way of your daily activities / sleep quality.

  daily records over the 4 weeks of treatment in relation to their baseline value.

Secondary Outcomes (5)

• Variation of total instant nasal symptoms (TSNi)

  over the 4 weeks of treatment

• Variation of each nasal symptom

  over the 4 weeks of treatment

• Variation of total ocular symptoms and in each specific ocular symptom

  over the 4 weeks of treatment

• Patient's overall impression of treatment efficacy at the end of the study

  over the 4 weeks of treatment

• Researcher's general impression at the end of the study

  over the 4 weeks of treatment

Study Arms (2)

Group I

EXPERIMENTAL

Drug names: Fluticasone Propionate - PLURAIR® brand Pharmaceutical form: Nasal spray (50mcg / dose) Administration: Topical nasal route Posology 02 jets in each nostril 1 time a day - Single daily topical nasal dose of 200 mcg / day (2 jets / nostril = 100 mcg / nostril), preferably in the morning, upon waking up and at the same time, for 4 weeks. Manufacturer: Libbs Farmacêutica Ltda. Presentation: Deliver 1 bottle of 120 doses in original packaging

Drug: Fluticasone Propionate

Group II

ACTIVE COMPARATOR

Fluticasone Propionate - FLIXONASE® brand Nasal spray (50mcg / dose) Topical nasal route 02 jets in each nostril once a day - Single daily topical nasal dose of 200 mcg / day (2 jets / nostril = 100 mcg / nostril), preferably in the morning, upon waking up and at the same time, for 4 weeks. GlaxoSmithKline. Deliver 1 bottle of 120 doses in original packaging

Drug: Fluticasone Propionate

Interventions

Fluticasone Propionate DRUG

Group I; Group II

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Libbs Farmacêutica LTDA: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In the present double-blind study, the original bottles of the two drugs under study (Plurair® and Flixonase®) had their labels sealed and were packed in identical secondary packaging (with specific label for clinical research), associated with a unique identification code. Page 75 of 207 Clinical Report LB1108 Version 1.0 of February 8, 2018 CONFIDENTIAL Libbs Farmacêutica Ltda. Each cartridge of the study drug had a unique identification code related to one of the treatment arms through an electronically generated list, stratified by center. Participants were allocated to one of two treatment groups at a 1: 1 ratio. This list was not accessible to the study doctor, study participant and team, in order to guarantee the study blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: July 4, 2014
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04