Drugs / Fluticasone/Salmeterol
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00531791 | Nov 2007 → Sep 2009 | chronic obstructive pulmonary disease | Laval University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2017-02-23 | GlaxoSmithKline | Results Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗
Results demonstrated statistically significant differences in favour of the ICS/LABA combinations to FP (p<0.001). |
| 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). |
| 2016-03-17 | 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. |
| 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. |
| 2014-09-08 | Nxera Pharma UK Limited | Results Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro Breezhaler and Seebri Breezhaler, and promotion agreement with Pfizer in the UK nxera.life ↗ |
| 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 ↗
There were no notable differences between UMEC (at either dose) added to FSC 250/50 mcg and placebo added to FSC 250/50 mcg in incidence rates of on-treatment adverse events or in changes from baseline in vital signs. |
| 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). |
| 2010-06-01 | GlaxoSmithKline | Regulatory GSK announces revised product labels for Serevent and Advair gsk.com ↗
today announced that it has received a letter from the U.S. Food and Drug Administration directing revisions to product labeling for its respiratory products Serevent® and Advair®. |
| 2010-02-17 | GlaxoSmithKline | Regulatory GSK statement on FDA’s proposed label revisions for some asthma medicines gsk.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluticasone/Salmeterol | “Effects of Fluticasone/Salmeterol (Advair®) in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation” NCT00531791 ↗ |
| Known as | Advair | “Effects of Fluticasone/Salmeterol (Advair®) in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation” NCT00531791 ↗ |
| Route | Inhaled | “Advair® 50/500 ug 2 inhalations twice daily” NCT00531791 ↗ |