ArticleCureus2026
An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD).
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Effectiveness and Safety of Budesonide/Formoterol in Asthma: A Systematic Review.Healthcare (Basel, Switzerland) · 2026Review
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA combination of inhaled corticosteroids (ICS) and long-acting β₂-agonists (LABA) is recommended for symptomatic asthma patients. Asthma control with single maintenance and reliever therapy (SMART) in patients remains poor with frequent nighttime awakenings, increased reliever use & severe exacerbations, including non-adherence. Once-daily FF/VI, an ultra LABA/ICS, has proven efficacy and safety in asthma with better adherence than multi-day regimens.
methodsThis prospective, multi-center, post-marketing (PROMISE-OD) study evaluated FF/VI DPI (100/25 mcg or 200/25 mcg) over 12 weeks in symptomatic asthma patients (≥12 years) on conventional therapies.
resultsAmong 178 enrolled patients, 177 completed the study (53.9% females & mean age 44.8±15 years). Mean trough FEV1 improved by 180.5±810.7 ml (p=0.003) at week 4 & by 258.8±846.6 ml (p<0.0001) at week 12. The mean ACQ-5 score also reduced by -0.8±0.8 at week 4 and -1.3±0.9 at week 12 (p<0.0001). Adverse events occurred in 15.7% of patients, with no SAEs reported. Rescue medication was low (3.4% at week 4 & 5.1% at week 12). High patient and physician satisfaction was also observed.
conclusionFF/VI DPI demonstrated significant improvements in lung function and asthma control with high patient satisfaction and a favorable safety profile, establishing it as a promising maintenance therapy for asthma management in Indian patients.
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