Drugs / Symbicort
Symbicort
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 2 milestones | |||||
| Filed | EU (EMA) | Symbicort Turbuhaler | asthma | 2019-05-20 | “A regulatory submission to expand the indication for Symbicort Turbuhaler as an anti-inflammatory reliever in mild asthma has been accepted in Europe.” astrazeneca.com ↗ |
| Filed | Japan (PMDA) | Symbicort | asthma | — | “AstraZeneca submitted a new drug application (NDA) in Japan in May, 2007.” astrazeneca.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | SYMBICORT | — | 2006-07-21 | fda.gov ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT01980615 | Nov → Dec 2013 | — | Pearl Therapeutics, Inc. | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT01432080 | Sep 2011 → Dec 2012 | bronchiolitis obliterans syndrome, cryptogenic organizing pneumonia | Maisonneuve-Rosemont Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 31 trial | ||||||
| Phase 3 | NCT00628758 | Dec 2005 → Sep 2008 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03924635 | Aug 2019 → Dec 2022 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02233803 | Nov 2014 → Dec 2015 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00576316 | Jan → Nov 2008 | asthma | AstraZeneca | Completed | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT01627158 Comparator | Jun → Oct 2012 | asthma | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 3 | NCT05322707 Comparator | Apr 2022 → Aug 2023 | asthma | Cipla Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04607629 Background | Jun 2018 → Apr 2019 | asthma | AO GENERIUM | Completed | No outcome recorded |
| Phase 3 | NCT03468790 Background | May 2018 → Jan 2021 | allergic asthma | Shanghai Biomabs Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT02495168 Comparator | Jan 2017 → May 2018 | asthma | Actavis Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02546297 Comparator | Sep 2017 → Sep 2020 | bronchiectasis | Shanghai Pulmonary Hospital, Shanghai, China | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2018-09-16 | AstraZeneca | Results The Lancet Respiratory Medicine publishes first Phase III trial for PT010 triple combination therapy in moderate to very severe chronic obstructive pulmonary disease astrazeneca.com ↗
PT010 also demonstrated reductions in the rate of moderate or severe COPD exacerbations versus PT009 and Symbicort (18% and 17% respectively), which were numerically but not statistically significant improvements. |
| 2018-01-26 | AstraZeneca | Results AstraZeneca reports top-line Phase III KRONOS trial results for PT010 triple combination therapy in chronic obstructive pulmonary disease astrazeneca.com ↗
In total, eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators. |
| 2016-09-06 | GlaxoSmithKline | Results GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress gsk.com ↗
In addition, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on closed triple and 41% on budesonide/formoterol (odds ratio 1.41; p<0.001). |
| 2016-06-20 | GlaxoSmithKline | Results FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients gsk.com ↗
The study met its two co-primary endpoints, demonstrating statistically significant improvements compared with twice-daily Symbicort® Turbohaler® (budesonide/formoterol 400/12mcg) in both lung function as measured by trough FEV1 (171mL, 95% confidence interval [148, 194] p<0.001), and health-related quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ) (-2.2 units, 95% confidence interval [-3.5, -1.0] p<0.001), at the end of the 24-week study period. |
| 2013-03-19 | AstraZeneca | Results Real world study comparing commonly prescribed COPD medicines shows choice of treatment has impact on patient outcomes astrazeneca.com ↗
Overall, budesonide/formoterol reduced the annual rate of moderate to severe exacerbations by 26% compared to fluticasone/salmeterol (0.80 vs. 1.09 /patient-year; p<0.0001). |
All press releases naming this drug 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Symbicort | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02495168 ↗ |
| Known as | Budesonide/Formoterol Fumarate Dihydrate | “Symbicort® (Budesonide/Formoterol Fumarate Dihydrate)” NCT02495168 ↗ |
| Known as | Symbicort MDI | “Symbicort MDI taken as 2 inhalations” NCT01980615 ↗ |
| Route | Inhaled | “2 inhalations every 12 hours for 3 months” NCT01432080 ↗ |