Drugs / salmeterol xinafoate
salmeterol xinafoate
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Aerivio Spiromax | — | 2016-08-18 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | SEREVENT | — | 1998-02-05 – 2002-03-22 | fda.gov ↗ |
| Approved | US (FDA) | SEREVENT | — | 1994-02-04 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT02260492 | Sep 2014 → May 2015 | asthma | Oriel Therapeutics | Completed | Met primary |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT01772368 | Jan → Jun 2013 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 2 | NCT01712451 | Aug 2011 → Oct 2012 | — | Neothetics, Inc | Completed | No outcome recorded |
| Phase 35 trials · 5 met primary | ||||||
| Phase 3 | NCT02245672 | Oct 2014 → Jul 2015 | asthma | Mylan Pharma UK Ltd. | Completed | Met primary |
| Phase 3 | NCT02139644 | Jun 2014 → Sep 2015 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT02141854 | Jun 2014 → Sep 2015 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| Phase 3 | NCT00565266 | May 2008 → May 2010 | asthma | Milton S. Hershey Medical Center | Completed | Met primary |
| Phase 3 | NCT00394368 | Nov 2004 → Sep 2005 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT00546234 | Nov 2007 → Jan 2014 | asthma | University of Alberta | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00461500 | Mar → Dec 2007 | asthma | GlaxoSmithKline | Completed | Missed primary |
| Comparator or background therapy7 trials | ||||||
| Phase 2 | NCT02433834 Comparator | May 2015 → Mar 2016 | asthma | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00403286 Comparator | Nov 2006 → May 2007 | chronic obstructive pulmonary disease | Dey | Completed | No outcome recorded |
| Phase 3 | NCT07858123 Comparator | Nov 2026 → Jun 2030 expected | asthma | Chiesi Farmaceutici S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02554786 Comparator | Dec 2015 → Nov 2018 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02571777 Comparator | Dec 2015 → Jun 2019 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00628758 Background | Dec 2005 → Sep 2008 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT06282861 Comparator | Feb 2024 → Jan 2025 | chronic obstructive pulmonary disease | Fundacio Privada Mon Clinic Barcelona | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2019-07-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder tevapharm.com ↗
AirDuo® Digihaler™ was approved in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. |
| 2017-12-21 | GlaxoSmithKline | Regulatory FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data gsk.com ↗ |
| 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). |
| 2016-09-05 | Boehringer Ingelheim | Results Simple Blood Test Combined with Exacerbation History May Help to Identify When to Add ICS to COPD Treatment prnewswire.com ↗
New results from the WISDOM study indicate that using ICS as part of a triple therapy regimen in COPD maintenance treatment reduces the likelihood of an exacerbation for a smaller number of people than previously thought. |
| 2016-04-08 | Boehringer Ingelheim | Results Lancet Publication: New Analysis Demonstrates Only Small Minority of Severe/Very Severe COPD Patients May Benefit from Adding ICS to SPIRIVA® HANDIHALER® (tiotropium bromide inhalation powder) + LABA Therapy prnewswire.com ↗
The WISDOM post-hoc analysis demonstrates that using the simple and commonly performed eosinophil blood count may provide a practical tool to help healthcare providers identify the small subset of patients who may benefit from the addition of ICS to SPIRIVA® HANDIHALER® ‡ + LABA therapy. |
| 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. |
| 2014-09-08 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents Pivotal Phase III Data for the Investigational Fixed-Dose Combination of Tiotropium + Olodaterol in COPD prnewswire.com ↗
Also presented at ERS for the first time, were data from the 52-week WISDOM (Withdrawal of Inhaled Steroids During Optimised bronchodilator Management) trial. |
| 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. |
| 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. |
| 2010-06-01 | GlaxoSmithKline | Regulatory GSK announces revised product labels for Serevent and Advair gsk.com ↗
GlaxoSmithKline [NYSE:GSK] 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 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | salmeterol xinafoate | “FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate...” NCT02139644 ↗11“FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and...” NCT01772368 ↗ “FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and...” NCT02141854 ↗ “Active ingredients: Fluticasone Propionate (FP)/Salmeterol Xinafoate (SLM) pMDI 125/25μg per actuation; Excipients: HFA-134a propellant.” NCT07858123 ↗ “Salmeterol xinafoate /fluticasone propionate 50/500 μg twice daily (b.i.d.) delivered via Accuhaler®” NCT02571777 ↗ |
| Known as | Salmeterol xinafoate/fluticasone propionate combination | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00461500 ↗ |
| Known as | Serevent | “Serevent diskus 50 mcg/dosage, 60 dosage” NCT00628758 ↗ |
| Known as | Serevent Diskus | “Serevent Diskus 50 μg” NCT02433834 ↗ |
| Action | Activate | “β2 adrenoceptor agonist” NCT01772368 ↗ |
| Route | Inhaled | “both delivered two inhalations b.i.d. via a pressurized metered dose inhaler.” PMID 17845589 ↗ Oct 2007 |