Advertisement

Topics

Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis

2014-07-23 21:11:44 | BioPortfolio

Summary

The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).

Description

- Rationale - Acute rhinosinusitis (ARS) is a condition caused by inflammation of the nose and the paranasal sinuses that generally lasts up to 4 weeks. Despite ARS being a self-limiting condition, untreated or inadequately treated sinus infection can lead to the development of complications. Uncomplicated ARS is a subset of ARS and is distinguished from the common cold by the persistence or the worsening of sinus inflammation after the usual period for recovery of viral infection of the nasal cavity (i.e., 10 days). Clinically the difference is based on the following criteria: symptoms are present at least 10 days but less than 4 weeks beyond the onset of upper respiratory symptoms OR symptoms worsen after 5 days from their onset.

In the primary care settings, ARS is often treated empirically with antibiotics although they are shown to provide limited benefit in the uncomplicated ARS population. Alternatively, the use of an intranasal corticosteroid (INS) to control symptoms of uncomplicated ARS is plausible based on clinically proven ability to reduce inflammation and mucosal swelling.

This study is a phase II study.

- Objective - The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with uncomplicated ARS.

- Study Design - This is a randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study. The study includes a 2-week post-treatment follow-up period.

Approximately 720 subjects will be randomized to one of three treatment groups for a period of 14 days: FFNS 110 mcg QD, FFNS 110 mcg BID, and placebo nasal spray.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Sinusitis, Acute

Intervention

FFNS 110 mcg BID, FFNS 110 mcg QD, Placebo Nasal Spray

Location

GSK Investigational Site
Ruse
British Columbia
Bulgaria
7000

Status

Recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:44-0400

Clinical Trials [1573 Associated Clinical Trials listed on BioPortfolio]

Comparator Study Evaluating Patient Preference Of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS)

The purpose of this replicate study to FFU105927 (NCT00519636) is to provide data on subject preference of FFNS as compared with FPNS.

Comparator Study Evaluating Patient Experience And Preference Of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS)

The purpose of this replicate study to FFU105924 (NCT00539006) is to provide data on subject preference of FFNS as compared with FPNS.

A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis

The purpose of this pilot study is to compare the effects (effectiveness and safety)of an intranasal corticosteroid (fluticasone furoate nasal spray [FFNS]) with a placebo nasal spray for ...

An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo

The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs...

Non-interventional Study With Ectoin Containing and/or Decongesting Nasal Spray in Patients With Rhinosinusitis

The goal of this non-interventional study is to investigate the efficacy and tolerability of an Ectoin containing Rhinosinusitis Nasal Spray (SNS01). Within the study, SNS01 will be used e...

PubMed Articles [7467 Associated PubMed Articles listed on BioPortfolio]

Cyclamen europaeum extract for acute sinusitis.

Acute sinusitis is a common reason for primary care encounters. It causes significant symptoms including facial pain, congested nose, headache, thick nasal mucus, fever, and cough and often results in...

Sinusitis in Children.

Acute bacterial sinusitis (ABS) mostly occurs as a complication of acute viral upper respiratory tract infection (URI), which is a common condition encountered in an outpatient setting. ABS manifests ...

A Simplified Geometric Model to Predict Nasal Spray Deposition in Children and Adults.

A mathematical approach was developed to estimate spray deposition patterns in the nasal cavity based on the geometric relationships between the emitted spray plume and the anatomical dimensions of th...

Rhinosectan spray (containing xyloglucan) on the ciliary function of the nasal respiratory epithelium; results of an in vitro study.

To assess the effects of Rhinosectan spray, a medical device containing xyloglucan, on nasal ciliary function (in MucilAir™Nasal cells).

Clinical research of different characteristics of fungal ball sinusitis.

The aim of this study is to investigate the clinical features of different subtypes of fungal ball sinusitis. Four hundred and forty-nine cases with fungal ball rhinosinusitis (FBS) were involved in t...

Medical and Biotech [MESH] Definitions

Inflammation of the NASAL MUCOSA in the SPHENOID SINUS. Isolated sphenoid sinusitis is uncommon. It usually occurs in conjunction with other paranasal sinusitis.

Inflammation of the NASAL MUCOSA in the ETHMOID SINUS. It may present itself as an acute (infectious) or chronic (allergic) condition.

Agents delivered into the nostrils in the form of a mist or spray.

Inflammation of the NASAL MUCOSA in one or more of the PARANASAL SINUSES.

A compound formed when iodoacetic acid reacts with sulfhydryl groups in proteins. It has been used as an anti-infective nasal spray with mucolytic and expectorant action.

More From BioPortfolio on "Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial