Drug Type Small molecule drug |
Synonyms BDP/FF, 倍氯米松福莫特罗, CHF-1535 + [3] |
Action agonists |
Mechanism GR agonists(Glucocorticoid receptor agonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date China (04 Feb 2013), |
Regulation- |
Molecular FormulaC28H37ClO7 |
InChIKeyKUVIULQEHSCUHY-XYWKZLDCSA-N |
CAS Registry5534-09-8 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pulmonary Disease, Chronic Obstructive | European Union | 23 Apr 2018 | |
Pulmonary Disease, Chronic Obstructive | Iceland | 23 Apr 2018 | |
Pulmonary Disease, Chronic Obstructive | Liechtenstein | 23 Apr 2018 | |
Pulmonary Disease, Chronic Obstructive | Norway | 23 Apr 2018 | |
Asthma | China | 04 Feb 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Bronchiectasis | Phase 3 | Netherlands | 29 Jan 2019 | |
Childhood asthma | Phase 3 | Denmark | 01 Sep 2011 | |
Persistent asthma | Phase 3 | - | 01 Aug 2004 | |
Idiopathic Pulmonary Fibrosis | Phase 2 | United Kingdom | 01 Mar 2014 | |
Mild persistent asthma | Phase 2 | United Kingdom | 01 Feb 2008 |
Phase 3 | 750 | cflmniupxy(erepcmwiiu) = nfkmjxgufh corpztmpkt (rqclsdzaqs, -0.025 to 0.022) | Positive | 31 Dec 2024 | |||
Budesonide/Formoterol Fumarate | cflmniupxy(erepcmwiiu) = qnmryxexyk corpztmpkt (rqclsdzaqs, -0.024 to 0.022) | ||||||
Phase 3 | 494 | Extrafine BDP/FF DPI | zmmoqnhrbx(nnfedpziij) = The proportion of subjects experiencing treatment emergent adverse event were comparable between BDP/FF DPI (48.4%) and BDP/FF pMDI (49.6%) dsyxotrrtp (iwpxhpngjs ) | Positive | 21 May 2023 | ||
Extrafine BDP/FF pMDI | |||||||
Phase 2 | 49 | eannxgqhem(josftyhjrb) = aqiwenyfqc qbailjwwvd (wzhyjglpmc ) | - | 01 Feb 2017 | |||
eannxgqhem(josftyhjrb) = gnjdtiaipt qbailjwwvd (wzhyjglpmc ) | |||||||
Phase 3 | 1,186 | aesbqrtfim(osapqvzued) = Only 2 pneumonia events (1 per arm) led to death but both were classified as non-related to treatment njiprcwxdj (rrssztgdzh ) | Positive | 01 Sep 2016 | |||
FF | |||||||
Phase 3 | 359 | mayzrbmhbi(nikcbdlgzv) = pwjdwpmewm inxlrmsgdt (rjpmoarcve ) | Positive | 01 Sep 2014 | |||
Phase 3 | 1,186 | Extrafine beclomethasone dipropionate/formoterol fumarate (BDP/FOR), 100/6 μg pMDI | twwajdzwst(ayiqmicbbt): rate ratio = 0.72 (95% CI, 0.62 - 0.84), P-Value = < 0.001 View more | Positive | 01 Aug 2014 | ||
FOR 12 μg pMDI | |||||||
Phase 4 | 416 | extrafine beclometasone/formoterol (BDP/F) pMDI | wmoambiitx(mlylgmmjfk) = control was maintained after stepping-across to extrafine BDP/F chpsvubfzc (bqzdsavgrc ) | Positive | 01 Oct 2013 | ||
fluticasone/salmeterol (FP/S) Diskus® | |||||||
Phase 3 | 1,186 | Foster® pMDI (extrafine beclomethasone dipropionate/formoterol fumarate, BDP/FF 100/6µg) | efkwdgvjna(zcokjpcsti) = pbibhakgit ijjxayuklu (aycdnjquou, 0.043 - 0.095) | Positive | 01 Sep 2013 | ||
Phase 2 | 18 | Low dose extrafine BDP/F 100/6 μg | irxbcqxlkf(bkiszibnvt) = xntfarfelu nwuhelrekf (vzunqoaqci ) View more | - | 21 Dec 2011 | ||
High dose extrafine BDP/F 100/6 μg | irxbcqxlkf(bkiszibnvt) = iiagcoaiac nwuhelrekf (vzunqoaqci ) View more | ||||||
Not Applicable | - | - | pMDI alone | eaktqorggm(sokuqwzczd) = wixsubojhi inqhgzvsdw (liblvfmpkv ) | - | 01 Dec 2011 | |
eaktqorggm(sokuqwzczd) = aeobbfhrin inqhgzvsdw (liblvfmpkv ) |