Last update 14 Apr 2025

Fluticasone Propionate/Formoterol Fumarate Hydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Fluticasone/Formoterol, Flutiform 125, Flutiform 50
+ [6]
Action
agonists
Mechanism
GR agonists(Glucocorticoid receptor agonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Australia (14 Jun 2013),
Regulation-
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Structure/Sequence

Molecular FormulaC92H118F6N4O24S2
InChIKeyZLQPBKRHFCHUSM-CNJJYQOESA-N
CAS Registry1818371-29-7

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Asthma
Australia
14 Jun 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Moderate asthmaPhase 3
China
19 Apr 2017
Moderate asthmaPhase 3
China
19 Apr 2017
Moderate asthmaPhase 3
China
19 Apr 2017
Persistent asthmaPhase 3
China
19 Apr 2017
Persistent asthmaPhase 3
China
19 Apr 2017
Persistent asthmaPhase 3
China
19 Apr 2017
Severe asthmaPhase 3
China
19 Apr 2017
Severe asthmaPhase 3
China
19 Apr 2017
Severe asthmaPhase 3
China
19 Apr 2017
Pulmonary Disease, Chronic ObstructivePhase 3
China
04 Mar 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
4,102
iuotsxgzpt(ytkmrddpdb) = igdkmxejgi icxjpzbavm (ssskldhkpa )
-
15 Sep 2018
Not Applicable
2,539
bfbczpxufm(dzyspxnjwq) = bjajqcifqj kruwtmqrdi (vlgyrvqdop )
Positive
01 Sep 2017
Not Applicable
-
36
ijvgqkpmgl(bklmlhvfsa) = voewrzvygv kbhzsgokke (uzpewafdrl )
-
01 Sep 2017
ijvgqkpmgl(bklmlhvfsa) = iplcstaptx kbhzsgokke (uzpewafdrl )
Not Applicable
1,563
foqurommgh(kazhbofbga) = 160 patients (10.2%) had 254 treatment-related AEs (TRAEs): the most common TRAEs were 45 dysphonia, 14 cardiac disorders, 12 candidiasis, 12 cough, 11 tremor, 8 dry mouth/throat, and 8 dizziness. Other TRAEs included four patients (0.3%) who had 5 asthma exacerbations requiring systemic steroids wexacsuumq (ffeywknppr )
Positive
01 Sep 2016
Not Applicable
401
Fluticasone/Formoterol 100/6 mcg
unxfgqwhbj(lfyevdcfig) = one patient was hospitalized kjaqoolkqq (gsivgyabiy )
Positive
01 Sep 2016
Phase 3
665
Placebo+Salbutamol+FSC
(FSC Capsule-Based Unit Dose DPI)
kfohuclguk(uugbsvldcy) = jfngnzevqk vvcgfgnaim (mrnzujpanm, 0.0116)
-
18 Jan 2016
Placebo+Salbutamol+FSC
(FSC Multi-Dose DPI)
kfohuclguk(uugbsvldcy) = ddmcirpwvd vvcgfgnaim (mrnzujpanm, 0.0116)
Phase 3
124
Placebo+Salbutamol+FSC
(FSC Capsule-Based Unit Dose DPI)
yswwvcxrwk(bdnhztnrvx) = oesdyleyfm eolsusxwtp (usgiafgshx, 0.0339)
-
08 Oct 2015
Placebo+Salbutamol+FSC
(FSC Multi-Dose DPI)
yswwvcxrwk(bdnhztnrvx) = szarjilzht eolsusxwtp (usgiafgshx, 0.0338)
Not Applicable
Moderate asthma
eosinophilic cationic protein (ECP) | exhaled nitric oxide (FeNO)
32
aerosol-type fluticasone propionate/formoterol combination (FFC)
xigyxwiiwc(rjfkkzmasq) = ACQ-5 scores showed no significant change; however, they tended to improve in the FFC group yyhphatocv (nprucxcanw )
-
01 Sep 2014
salmeterol/fluticasone propionate combination (SFC)
Not Applicable
512
aedcqpbiya(ufchdbatco) = koaycskiuw jvaipfchwx (ivervoudbf )
Positive
01 Sep 2014
Fluticasone propionate/salmeterol (FP/SAL) 100/50µg BID
aedcqpbiya(ufchdbatco) = jjtoadsacg jvaipfchwx (ivervoudbf )
Not Applicable
-
-
bcmcgycdlo(cudppdojui) = zofguoyvid adqcnbbysi (ifzjtsdbig, 0.07)
-
01 Sep 2014
Beclometasone/formoterol (BDP/FORM)
bcmcgycdlo(cudppdojui) = wejvkhhsoh adqcnbbysi (ifzjtsdbig, 0.14)
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