Real-life effectiveness of asthma treatment with a fixed-dose fluticasone/formoterol pressurised metered-dose inhaler – Results from a non-interventional study

Schmidt, Olaf; Petro, W; Hoheisel, Gerhard; Kanniess, Frank; Oepen, Petra; Langer-Brauburger, Birgit

doi:10.1016/j.rmed.2017.08.017

Cited by 16 publications

(21 citation statements)

References 43 publications

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“…Stratification by the FDC ICS/LABA type showed that, despite the much lower sample size, switching from DPI to FP/FORM pMDI was still associated with significantly better asthma control. Previous studies have reported FP/FORM to be efficacious in improving asthma control and decreasing asthma exacerbations in clinical trial settings as well as in a prospective non‐interventional post‐authorization safety study setting . This study supports the effectiveness of FP/FORM pMDI in the context of real‐world setting.…”

Section: Discussionsupporting

confidence: 81%

Real‐life effectiveness of inhaler device switch from dry powder inhalers to pressurized metred‐dose inhalers in patients with asthma treated with ICS/LABA

et al. 2019

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Background and objective Mixed inhaler device use for asthma is associated with worse inhaler technique and outcomes. Given that relievers are commonly prescribed as pressurized metred‐dose inhalers (pMDI), changing preventers from dry powder inhalers (DPI) to pMDI may improve asthma outcomes. This study aimed to assess the persistence and effectiveness of switching from DPI to pMDI for inhaled corticosteroid and long‐acting β2‐agonist combination therapy (ICS/LABA). Methods This was a historical cohort study using Ajou University Hospital (Korea) patient records. Persistence of switch was defined as receiving ≥1 pMDI and no DPI after the switch. Effectiveness of switch was assessed as the proportion without severe asthma exacerbation and the proportion achieving risk domain asthma control (RDAC; no asthma‐related hospitalization, antibiotics without upper respiratory diagnosis or acute course of oral corticosteroids) and overall asthma control (OAC; RDAC and ≤ 200 μg salbutamol/≤500 μg terbutaline average daily dose) comparing 1 year after and before the switch. Results Within 85 patients who switched from DPI to pMDI and persisted for a year, higher proportion were free from asthma exacerbation after the switch (mean difference in proportion = 0.129, 95% CI: 0.038–0.220). Switching to pMDI was also associated with better RDAC (75.3% vs 57.7%, P = 0.001) and OAC (57.7% vs 45.9%, P = 0.021). From the entire 117 patients who switched to fixed‐dose combination (FDC)/ICS LABA pMDI, 76.1% (95% CI: 69.0–100.0%) patients persisted in the following 6 months. Conclusion Switching to and persisting with pMDI was associated with decreased asthma exacerbations and improved asthma control. The majority of patients persisted with the switch to pMDI for ICS/LABA treatment.

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Section: Discussionsupporting

confidence: 81%

Real‐life effectiveness of inhaler device switch from dry powder inhalers to pressurized metred‐dose inhalers in patients with asthma treated with ICS/LABA

et al. 2019

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“… 9 Dysphonia was also the most common treatment-related AE in the ffAiRNeSS study. 28 The rates of bronchopneumonia and oropharyngeal candidiasis were low (0.1% in both cases).…”

Section: Discussionmentioning

confidence: 81%

“…Together with a 12-month non-interventional study of fluticasone/formoterol conducted in Germany (ffAiRNeSS), 28 the PASS reported here was conducted as part of an agreed EU RMP. The current study was designed with the primary objective of collecting safety information during routine clinical use of fluticasone/formoterol, and also monitored the effectiveness of this ICS/LABA in achieving asthma control in real-world practice across eight European countries.…”

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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“…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]. 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].…”

Section: Fp/form Clinical Datamentioning

confidence: 89%

“…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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Real-life effectiveness of asthma treatment with a fixed-dose fluticasone/formoterol pressurised metered-dose inhaler – Results from a non-interventional study

Abstract: In this one-year study, FP/FORM treatment was associated with clinically relevant improvements in asthma status in a diverse population of patients under real-life conditions.

Cited by 16 publications

References 43 publications

Real‐life effectiveness of inhaler device switch from dry powder inhalers to pressurized metred‐dose inhalers in patients with asthma treated with ICS/LABA

Real‐life effectiveness of inhaler device switch from dry powder inhalers to pressurized metred‐dose inhalers in patients with asthma treated with ICS/LABA

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

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Real-life effectiveness of asthma treatment with a fixed-dose fluticasone/formoterol pressurised metered-dose inhaler – Results from a non-interventional study

Abstract: In this one-year study, FP/FORM treatment was associated with clinically relevant improvements in asthma status in a diverse population of patients under real-life conditions.

Cited by 16 publications

References 43 publications

Real‐life effectiveness of inhaler device switch from dry powder inhalers to pressurized metred‐dose inhalers in patients with asthma treated with ICS/LABA

Real‐life effectiveness of inhaler device switch from dry powder inhalers to pressurized metred‐dose inhalers in patients with asthma treated with ICS/LABA

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

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