A Randomized Pragmatic Trial of Changing to and Stepping Down Fluticasone/Formoterol in Asthma

Usmani, Omar; Kemppinen, Anu; Gardener, Elizabeth; Thomas, Vicky; Konduru, Priyanka Raju; Callan, Christina; McLoughlin, Andrew; Woodhead, Vanessa; Brady, Adam; Juniper, Elizabeth F.; Barnes, Peter J.; Price, David

doi:10.1016/j.jaip.2017.02.006

Cited by 31 publications

(43 citation statements)

References 25 publications

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“…In recognition of these issues, a number of pragmatic RCTs and observational studies have been conducted in heterogeneous asthma populations in recent years. 25 – 27 …”

Section: Discussionmentioning

confidence: 99%

Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

Backer

Ellery

Borzova³

et al. 2018

Ther Adv Respir Dis

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Introduction:In recognition of the value of long-term real-world data, a postauthorization safety study of the inhaled corticosteroid (ICS) fluticasone propionate and long-acting β2-agonist (LABA) formoterol fumarate (fluticasone/formoterol; Flutiform®) was conducted.Methods:This was a 12-month observational study of outpatients with asthma aged ⩾ 12 years in eight European countries. Patients were prescribed fluticasone/formoterol according to the licensed indication, and independently of their subsequent enrolment in the study. They were then treated according to local standard practice. The study objectives were to evaluate the safety and effectiveness of fluticasone/formoterol under real-world conditions.Results:The safety population for this study comprised 2539 patients (mean age 47.7 years; 94.3% aged ⩾ 18 years; 63.4% female). Most patients (1538/2539, 60.6%) had switched to fluticasone/formoterol from another ICS/LABA, primarily due to lack of efficacy (1150/2539, 45.3%). Three quarters (77.4%) of patients were treated for 12 months, and 80.6% continued fluticasone/formoterol treatment after the study. Adverse events (AEs) occurred in 60.0% patients, and 10.2% had AEs considered possibly related to fluticasone/formoterol [most commonly asthma exacerbation (2.0% patients), dysphonia (1.8%) and cough (1.1%)]. Thirty-six severe AEs, but no serious AEs, were considered possibly related to fluticasone/formoterol. The proportion of patients with controlled asthma (based on Asthma Control Test score ⩾ 20) increased from 29.4% at baseline to 67.4% at study end (last observation carried forward). The proportion of patients experiencing at least one severe exacerbation decreased from 35.8% in the year prior to enrolment to 9.8% during the study. Improvements from baseline to study end were also observed in Asthma Quality of Life scores and physician/patient reports of satisfaction with treatment.Conclusion:In this real-world postauthorization safety study, fluticasone/formoterol demonstrated a safety profile consistent with that seen in controlled clinical trials, with effectiveness in improving asthma control.

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“…In recognition of these issues, a number of pragmatic RCTs and observational studies have been conducted in heterogeneous asthma populations in recent years. 25 – 27 …”

Section: Discussionmentioning

confidence: 99%

Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

Backer

Ellery

Borzova³

et al. 2018

Ther Adv Respir Dis

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“…Real-world data from non-interventional studies in over 4000 patients with asthma support the effectiveness and safety/ tolerability of FP/FORM pMDIs in general clinical practice [29,37]. In addition, real-world data from a randomized pragmatic trial demonstrated that asthma control was maintained when the FP/ FORM pMDI dose was stepped down from high to medium [36]. Analyses indicate that the particle size characteristics of FP/FORM are well suited to the drug deposition requirements of ICS/LABA combinations, with a high fine-particle fraction that should help promote increased lung deposition with reduced oropharyngeal deposition [39].…”

Section: Fp/form Clinical Datamentioning

confidence: 92%

“…An extensive clinical dataset exists for FP/FORM administered via a pMDI (Table 2) [29][30][31][32][33][34][35][36][37][38]. Furthermore, long-term data from two clinical studies have demonstrated good efficacy, safety, and tolerability with this ICS/LABA combination, including a low rate of exacerbations, over study periods of up to 60 weeks [33,35].…”

Section: Fp/form Clinical Datamentioning

confidence: 99%

An innovative corticosteroid/long-acting β₂-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma

Usmani

Roche

Marshall

et al. 2019

Expert Opinion on Drug Delivery

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Introduction: Incorrect inhaler technique is one reason why the efficacies of inhaled asthma treatments in clinical trials and effectiveness in the real world differ. Inhaler technique is critical for drug delivery to the lungs; incorrect technique negatively impacts asthma control and long-term outcomes. Breath-triggered inhalers (BTIs) can simplify drug administration and are suitable for most patients, including those with reduced inspiratory flow. Until recently, no inhaled corticosteroid/long-acting β 2-agonist combination BTI was available in Europe. The flutiform ® (fluticasone propionate/formoterol fumarate [FP/FORM]) k-haler ® is the first combination BTI now approved in Europe for asthma maintenance treatment. Areas covered: We review studies examining the challenges posed to patients by different inhaler types and explore evidence demonstrating the clinical efficacy of FP/FORM administered via a pressurized metered-dose inhaler. We also review the pharmacokinetic/pharmacodynamic studies supporting FP/ FORM k-haler use, and consider data showing high lung deposition with the device. Finally, we review patient experiences using the BTI, device characteristics, and health economic aspects. Expert opinion: Despite the availability of therapies, asthma control levels remain low, and there is a clear need for easy-to-use inhalers. Research to increase our understanding of critical errors with each inhaler and how to overcome them is important for improving care.

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“…Risks when reducing asthma medications: Although the stepping down treatment through published studies showed safety (no harm to effi ciency of treatment) [11], its failure risk of Omar S. Usmani, et al (2017) showed that the history of exacerbation during previous 12 months was a signifi cant predictor of occurring exacerbation when stepping down [13].…”

Section: Barriers To Stepping Down Strategy Of Inhaled Corticosteroidmentioning

confidence: 99%

Barriers and solutions to stepping down asthma treatment

Nguyen-Ho¹

2020

Open J Asthma

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A Randomized Pragmatic Trial of Changing to and Stepping Down Fluticasone/Formoterol in Asthma

Cited by 31 publications

References 25 publications

Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

An innovative corticosteroid/long-acting β₂-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma

Barriers and solutions to stepping down asthma treatment

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A Randomized Pragmatic Trial of Changing to and Stepping Down Fluticasone/Formoterol in Asthma

Cited by 31 publications

References 25 publications

Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

Non-interventional study of the safety and effectiveness of fluticasone propionate/formoterol fumarate in real-world asthma management

An innovative corticosteroid/long-acting β2-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma

Barriers and solutions to stepping down asthma treatment

Contact Info

Product

Resources

About

An innovative corticosteroid/long-acting β₂-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma