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A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). The primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Fluticasone furoate inhalation powder, Fluticasone propionate inhalation powder, Placebo inhalation powder
GSK Investigational Site
Not yet recruiting
Published on BioPortfolio: 2014-07-24T14:00:43-0400
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate ...
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol...
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Pe
This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently ...
To compare the efficacy and safety profiles of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder (test product) and ADVAIR DISKUS (fluticasone propionate 100 mcg and s...
The Asthma Salford Lung Study demonstrated the effectiveness of initiating once-daily fluticasone furoate/vilanterol (FF/VI) versus continuing usual care in asthma patients in UK primary care . Her...
Dry powder inhalers (DPI) are effective but forceful inhalation required to fluidize the powder may be difficult for children and patients with airway disease. Inspiromatic is a new generation active ...
COPD patients have increased risk of pneumonia when treated with fluticasone propionate (FP), whereas this is generally not the case with budesonide (BUD) treatment. We hypothesized that BUD and FP di...
A fixed-dose combination of intranasal azelastine hydrochloride-fluticasone propionate (MP-AzeFlu) is the most effective treatment of allergic rhinitis (AR), but its onset of action requires further i...
The patients' inhalation flow pattern is one of the significant determinants for clinical performance of inhalation therapy. However, the development of inhalation flow meters for various inhalation d...
A drug combination of fluticasone and salmeterol that is used as an inhaler formulation to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
A device that delivers medication to the lungs in the form of a dry powder.
Method of using a polycrystalline powder and Rietveld refinement (LEAST SQUARES ANALYSIS) of X-RAY DIFFRACTION or NEUTRON DIFFRACTION. It circumvents the difficulties of producing single large crystals.
A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.
Inhalation of oxygen aimed at restoring toward normal any pathophysiologic alterations of gas exchange in the cardiopulmonary system, as by the use of a respirator, nasal catheter, tent, chamber, or mask. (From Dorland, 27th ed & Stedman, 25th ed)
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Asthma is caused by inflammation of small tubes, called bronchi, which carry air in and out of the lungs. If you have asthma, the bronchi will be inflamed and more sensitive than normal. When you come into contact with something that irritates your...