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fluticasone propionate DISKUS

Phase 3

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Last Updated: Jan 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment290

FDA Designations

No designations recorded

Clinical trial landscape

fluticasone propionate DISKUS · 1 trial · 1 indication

Phase 3 1
NCT00549146Treatment Of Partial Reversible Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic Obstructive
COMPLETED290 Analytics
PHASE3COMPLETED
Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.

Secondary Endpoints

Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50).
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
fluticasone propionate/salmeterol 250/50 DISKUS combination productDRUG -
fluticasone propionate DISKUS 500mcgDRUG -
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion criteria: * Established history of chronic obstructive pulmonary disease (COPD). * Lung function parameters: FEV1/FVC ratio \< 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL. * Signed and dated informed c...

Countries:Netherlands
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Frequently asked questions about fluticasone propionate DISKUS

What is fluticasone propionate DISKUS used for in Chronic Obstructive Pulmonary Disease?

Fluticasone propionate DISKUS is used for the treatment of partial reversible Chronic Obstructive Pulmonary Disease (COPD). It is a small molecule developed by GSK plc for the respiratory therapeutic area. The drug is delivered via the DISKUS inhalation device and is currently in Phase 3 clinical development.

What does fluticasone propionate DISKUS target?

Fluticasone propionate DISKUS is a corticosteroid that works by reducing inflammation in the airways. It is used in the treatment of Chronic Obstructive Pulmonary Disease (COPD) to help improve lung function and manage symptoms. The drug is administered through the DISKUS dry powder inhaler.

Who makes fluticasone propionate DISKUS?

Fluticasone propionate DISKUS is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The drug is being investigated for the treatment of Chronic Obstructive Pulmonary Disease (COPD) and is currently in Phase 3 clinical trials.

What phase is fluticasone propionate DISKUS in?

Fluticasone propionate DISKUS is in Phase 3 clinical development for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed with 290 participants enrolled.

What clinical trials is fluticasone propionate DISKUS in?

Fluticasone propionate DISKUS has one completed Phase 3 clinical trial registered under NCT00549146. The trial, titled 'Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease', enrolled 290 participants in the Netherlands. It was a randomized, double-blind study without a control group, involving patients aged 40 years and older.

Is fluticasone propionate DISKUS the same as fluticasone propionate?

Fluticasone propionate DISKUS is a specific formulation of fluticasone propionate delivered via the DISKUS dry powder inhaler device. The DISKUS version is designed for inhalation in the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is developed by GSK plc and is currently in Phase 3 clinical trials.