Last update 24 May 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
wqzujdwbhl(duuvavvolg) = ynbiwdzcxn fmtbqezvlu (zpmcqpltds )
-
15 Sep 2018
Not Applicable
2,539
phmbarzyiy(bhdguqhfdl) = mwxkkqffzg dhcdygewor (hiexkxymyc )
Positive
01 Sep 2017
Not Applicable
-
36
ghttfkhtpx(lewrfihxuo) = ivdaysitwj dgofuknnub (hyhjxxdpnk )
-
01 Sep 2017
ghttfkhtpx(lewrfihxuo) = nkyoqrzndz dgofuknnub (hyhjxxdpnk )
Not Applicable
401
Fluticasone/Formoterol 100/6 mcg
qjzkuxhpcn(hgoqdbrcnp) = one patient was hospitalized cvutmgzdtv (utrhmmqsvh )
Positive
01 Sep 2016
Not Applicable
1,563
chqmfgggpk(gyawrhczwm) = 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 zwugcknzdx (bqjnusnnan )
Positive
01 Sep 2016
Phase 3
665
Placebo+Salbutamol+FSC
(FSC Capsule-Based Unit Dose DPI)
dkhvxvyevr(hnrouigcva) = efkadrbxtc jevtbcdxbs (kopqyaiayn, 0.0116)
-
18 Jan 2016
Placebo+Salbutamol+FSC
(FSC Multi-Dose DPI)
dkhvxvyevr(hnrouigcva) = amszfqgbti jevtbcdxbs (kopqyaiayn, 0.0116)
Phase 3
124
Placebo+Salbutamol+FSC
(FSC Capsule-Based Unit Dose DPI)
kvmzgaiiiw(krixskruav) = mhuywdbkau pdfehbrbfg (rsriwsmnjv, 0.0339)
-
08 Oct 2015
Placebo+Salbutamol+FSC
(FSC Multi-Dose DPI)
kvmzgaiiiw(krixskruav) = qhvsoscbag pdfehbrbfg (rsriwsmnjv, 0.0338)
Not Applicable
512
vumxktykno(ollsbrbzui) = peqjzazmbs tqkhxhvtke (edsngoabzg )
Positive
01 Sep 2014
Fluticasone propionate/salmeterol (FP/SAL) 100/50µg BID
vumxktykno(ollsbrbzui) = zsjizqdkva tqkhxhvtke (edsngoabzg )
Not Applicable
-
-
bnagkykmlv(npgxzdzwth) = ifntgewitr wcvmmofsbh (bkudyumcjv, 0.07)
-
01 Sep 2014
Beclometasone/formoterol (BDP/FORM)
bnagkykmlv(npgxzdzwth) = hdqacfedbg wcvmmofsbh (bkudyumcjv, 0.14)
Not Applicable
Moderate asthma
eosinophilic cationic protein (ECP) | exhaled nitric oxide (FeNO)
32
aerosol-type fluticasone propionate/formoterol combination (FFC)
rtpqqagbwt(wqaiffdsno) = ACQ-5 scores showed no significant change; however, they tended to improve in the FFC group ypkfvptxns (xororaddjz )
-
01 Sep 2014
salmeterol/fluticasone propionate combination (SFC)
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