Asset profile

fluticasone propionate/salmeterol

Small molecule

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Reliablesignal

Evidence outlook · lead readout

NCT01978119 · Asthma

The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.

NCT01978119: Participants were randomized to receive both inhaler devices in a double-blind crossover design, so each patient effectively served as their own comparator between the capsule-based and multi-dose delivery systems. The primary endpoint, change in trough FEV1 (a hard lung-function measure), showed a difference of 0.028 L between devices with a 95% CI of -0.024 to 0.080 L, which fell entirely inside the pre-specified non-inferiority margin, meaning the two devices were confirmed to work equivalently as intended.

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Competitive landscape

65 competitors in this universe: 5 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 38 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Fluticasone Propionate / Salmeterol: this drugPhase 3Small moleculeGlucocorticoid receptor / Beta-2 adrenergic receptor
Albuterol / Budesonide (Airsupra)ApprovedCombinationBeta-2 adrenergic receptor, Glucocorticoid receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor
Fluticasone Furoate / VilanterolApprovedSmall moleculeBeta-2 adrenergic receptor, Glucocorticoid receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor
Fluticasone Propionate / Salmeterol (Advair HFA)ApprovedCombinationGlucocorticoid receptor, Beta-2 adrenergic receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor
GW815SF (Advair HFA)ApprovedSmall moleculeGlucocorticoid receptor / Beta-2 adrenergic receptor
Indacaterol Maleate / Mometasone FuroatePhase 3—Glucocorticoid receptor / Beta-2 adrenergic receptor
Albuterol (Armstrong Albuterol HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol HFA (Armstrong's)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol HFA (Proventil HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol Sulfate (Armstrong)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol Sulfate (Provenetil-HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
AminophyllineApprovedSmall moleculePhosphodiesterase (multi-subtype)
Beclomethasone (QVAR)ApprovedSmall moleculeGlucocorticoid receptor
Beclomethasone Dipropionate / Formoterol Fumarate / GlycopyrrolateApprovedSmall moleculeGlucocorticoid receptor / Beta-2 adrenergic receptor / Muscarinic M3 receptor (ICS/LABA/LAMA triple combination)
Benralizumab (Fasenra)ApprovedMonoclonal antibodyIL-5 receptor alpha, IL-5 receptor alpha (IL-5Rα / CD125); Fc region additionally engages FcγRIIIa on NK cells (ADCC), IL-5 receptor alpha (IL5RA) on eosinophils/basophils
Budesonide (Pulmicort)ApprovedSmall moleculeGlucocorticoid receptor agonist

…and 50 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

No upcoming readouts on record for this asset.

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (13)
Phase 2 (4)
Phase 1/2 (1)
Phase 1 (4)
Phase 4 (27)
Early phase / not applicable (2)
Used as active comparator (11)
Appears in other studies (11)