Drugs / Salmeterol/Fluticasone propionate
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00158834 | Nov 1999 → ? | asthma | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2017-02-23 | GlaxoSmithKline | Results Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗
In this positive study we have demonstrated non-inferiority for once-daily Relvar versus twice-daily Seretide on lung function. |
| 2016-09-01 | GlaxoSmithKline | Results NEJM publishes results of GSK’s long-term LABA safety study of Advair® Diskus® in children aged 4-11 years with asthma gsk.com ↗
In the study a non-statistically significant reduction of 14% was observed in the risk of time-to-first asthma exacerbation for FSC compared to FP (HR 0.859; 95% CI 0.729, 1.012). |
| 2016-08-31 | Novartis Pharmaceuticals | Results AirFluSal® Forspiro® showed superiority at 12 months over Seretide® Diskus®[1] in persistence to treatment novartis.com ↗
New study shows that rate of patient persistence using Sandoz AirFluSal Forspiro is twice as high as for reference product Seretide® Diskus®. |
| 2016-03-17 | GlaxoSmithKline | Results GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of children aged 4-11 years with asthma gsk.com ↗
The primary safety endpoint of the study showed FSC twice-daily (100/50mcg, 250/50mcg) demonstrated non-inferiority compared to corresponding doses of FP twice-daily (100mcg, 250mcg), on the risk of serious asthma-related events, Hazard Ratio (HR) 1.285, (95% CI 0.726, 2.272) p=0.006. |
| 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. |
| 2015-10-27 | GlaxoSmithKline | Results GSK’s Advair® Diskus® achieves primary endpoint in LABA safety study of patients with asthma gsk.com ↗
There were a total of 67 patients with serious asthma-related events across the study with 34 patients with events on FSC treatment and 33 patients with events on FP treatment. |
| 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. |
| 2014-05-19 | GlaxoSmithKline | Results GSK presents positive data at ATS 2014 from study evaluating efficacy and safety of Incruse™ Ellipta® added to Advair® Diskus® in patients with COPD gsk.com ↗ |
| 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. |
| 2012-03-23 | GlaxoSmithKline | Results GSK and Theravance announce completion of the Relovair™* registrational programme and topline results from Relovair™ vs. Advair® phase III studies in COPD gsk.com ↗
In the first study, FF/VI demonstrated superiority over FP/SAL on the predefined primary endpoint of 0-24 hour weighted mean FEV1 (p<0.001). |
| 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. |
All press releases naming this drug 14 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Salmeterol/Fluticasone propionate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00158834 ↗ |
| Known as | Seretide | “Salmeterol/Fluticasone Propionate Combination Product (Seretide®)” NCT00158834 ↗ |