Drugs / fluticasone propionate/salmeterol
last change Dec 2017 re-read 9 days ago

fluticasone propionate/salmeterol

Developed for
chronic obstructive pulmonary disease
Investigated by
GlaxoSmithKline · The Korean Academy of Tuberculosis and Respiratory Diseases

Trials 1

2009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT00864812 Mar 2009 → Mar 2010 chronic obstructive pulmonary disease The Korean Academy of Tuberculosis and Respiratory Diseases Completed No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2017-12-21 GlaxoSmithKline Regulatory FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data gsk.com ↗
These labelling updates were approved on December 20th 2017, after a review of safety data from 4 randomized controlled safety trials submitted by three companies, including GSK.
2016-03-06 GlaxoSmithKline Results NEJM publishes results of GSK’s long-term LABA safety study of Advair ® Diskus® in adults and adolescents with asthma gsk.com ↗
This was assessed by the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations) and showed that Advair had a safety profile comparable to FP, including no asthma-related deaths in either arm.
2015-05-19 GlaxoSmithKline Results GSK presents data at ATS on the role of blood eosinophil levels as a potential biomarker in the treatment of COPD gsk.com ↗
GSK today presented two abstracts at the American Thoracic Society (ATS) meeting that provide data on the role of blood eosinophils as a potential biomarker to determine responsiveness to treatment with an inhaled corticosteroid (ICS) in patients with COPD.
2014-03-14 GlaxoSmithKline Results GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS® in patients with COPD gsk.com ↗
We are pleased to announce the results from these positive studies, which provide physicians with further data regarding UMEC/VI as a treatment option for appropriate patients with COPD.
2012-01-09 GlaxoSmithKline Results GSK and Theravance announce initial outcomes from pivotal Phase III studies for once-daily Relovair™* in COPD and asthma gsk.com ↗
There was no statistical difference between FF/VI and FP/SAL.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as fluticasone propionate/salmeterol ClinicalTrials.gov intervention name — accepted as the source's own label NCT00864812 ↗
Known as fluticasone propionate/salmeterol (FSC): Seretide “fluticasone propionate/salmeterol (FSC): Seretide” NCT00864812 ↗
Known as FSC “tiotropium with fluticasone propionate/salmeterol (FSC)” NCT00864812 ↗