Drugs / fluticasone propionate/salmeterol
last change Dec 2017 re-read 3 minutes ago

fluticasone propionate/salmeterol

Developed for
chronic obstructive pulmonary disease
Investigated by
GlaxoSmithKline

Trials 1

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT00269087 Jan 2005 → Oct 2006 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

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 ↗
The FDA also approved updates to the Warnings and Precautions section of labelling for the ICS/LABA class.
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.
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 ↗
In each of the studies UMEC/VI achieved a statistically significant improvement in lung function, measured as weighted mean forced expiratory volume in one second (wm FEV1) over 0-24 hours at the end of the 12 week study (day 84), compared to either dose of FSC.

Evidence & citations 1 cited value

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 NCT00269087 ↗