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

Omar Usmani*, Nicolas Roche, Jonathan Marshall, Helen Danagher, David Price

*Corresponding author for this work

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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 β2-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.Abbreviations: AUCt: area under the plasma concentration-time curve from the time of dosing to the last measurable concentration; BDP: beclometasone dipropionate; BTI: breath-triggered inhaler; BUD: budesonide; CI: confidence interval; Cmax: maximum observed plasma concentration; DPI: dry powder inhaler; FDC: fixed-dose combination; FEV1: forced expiratory volume in 1 s; FORM: formoterol fumarate; FP: fluticasone propionate; HCP: health-care professional; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; OR: odds ratio; PIL: patient information leaflet; pMDI: pressurized metered-dose inhaler; SAL: salmeterol xinafoate.

Original languageEnglish
Pages (from-to)1367-1380
Number of pages14
JournalExpert Opinion on Drug Delivery
Volume16
Issue number12
Early online date28 Nov 2019
DOIs
Publication statusPublished - 2019

Fingerprint

Nebulizers and Vaporizers
Adrenal Cortex Hormones
Asthma
Lung
Therapeutics
Metered Dose Inhalers
Fluticasone
flutiform
Formoterol Fumarate
Dry Powder Inhalers
Beclomethasone
Budesonide
Equipment and Supplies
Forced Expiratory Volume
Expert Testimony
Pharmaceutical Preparations
Pharmacokinetics
Odds Ratio
Economics
Clinical Trials

Keywords

  • Asthma
  • breath-triggered inhaler
  • fluticasone propionate/formoterol fumarate
  • inhaled corticosteroid/long-acting β2-agonist
  • maintenance therapy
  • pressurized metered-dose inhaler

Cite this

An innovative corticosteroid/long-acting β2-agonist breath-triggered inhaler : facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma. / Usmani, Omar; Roche, Nicolas; Marshall, Jonathan; Danagher, Helen; Price, David.

In: Expert Opinion on Drug Delivery, Vol. 16, No. 12, 2019, p. 1367-1380.

Research output: Contribution to journalArticle

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abstract = "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 β2-agonist combination BTI was available in Europe. The flutiform{\circledR} (fluticasone propionate/formoterol fumarate [FP/FORM]) k-haler{\circledR} 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.Abbreviations: AUCt: area under the plasma concentration-time curve from the time of dosing to the last measurable concentration; BDP: beclometasone dipropionate; BTI: breath-triggered inhaler; BUD: budesonide; CI: confidence interval; Cmax: maximum observed plasma concentration; DPI: dry powder inhaler; FDC: fixed-dose combination; FEV1: forced expiratory volume in 1 s; FORM: formoterol fumarate; FP: fluticasone propionate; HCP: health-care professional; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; OR: odds ratio; PIL: patient information leaflet; pMDI: pressurized metered-dose inhaler; SAL: salmeterol xinafoate.",
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note = "OS Usmani and/or his department has received research grants, unrestricted educational grants, and/or fees for lectures and advisory board meetings from Aerocrine, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Edmond Pharma, GlaxoSmithKline, Napp, Mundipharma International, Prosonix, Sandoz, Takeda, Zentiva. N Roche reports grants and personal fees from Boehringer Ingelheim, Novartis, Pfizer and personal feed from Teva, GlaxoSmithKline, AstraZeneca, Chiesi, Mundipharma, Cipla, Sanofi, Sandoz, 3M, Trudell, Zambon. J Marshall and H Danagher report being an employee of Mundibiopharma Ltd., at the time of writing. D Price is a board member with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma Ltd., Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma Ltd., Napp, Novartis, Pfizer, Teva Pharmaceuticals, Threvance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd.) from AKL Research and Development Ltd., AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia, Mylan, Mundipharma Ltd., Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, Zentiva (Sanofi Generics); payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Munipharma Ltd., Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma Ltd., Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma Ltd., Napp, Novartis, Teva Pharmaceuticals; funding for patient enrollment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74{\%} of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74{\%} of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is a peer reviewer for grant committees of the Efficacy and Mechanism Evaluation program, and Health Technology Assessment.",
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T1 - An innovative corticosteroid/long-acting β2-agonist breath-triggered inhaler

T2 - facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma

AU - Usmani, Omar

AU - Roche, Nicolas

AU - Marshall, Jonathan

AU - Danagher, Helen

AU - Price, David

N1 - OS Usmani and/or his department has received research grants, unrestricted educational grants, and/or fees for lectures and advisory board meetings from Aerocrine, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Edmond Pharma, GlaxoSmithKline, Napp, Mundipharma International, Prosonix, Sandoz, Takeda, Zentiva. N Roche reports grants and personal fees from Boehringer Ingelheim, Novartis, Pfizer and personal feed from Teva, GlaxoSmithKline, AstraZeneca, Chiesi, Mundipharma, Cipla, Sanofi, Sandoz, 3M, Trudell, Zambon. J Marshall and H Danagher report being an employee of Mundibiopharma Ltd., at the time of writing. D Price is a board member with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Mylan, Mundipharma Ltd., Napp, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; consultancy agreements with Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Mylan, Mundipharma Ltd., Napp, Novartis, Pfizer, Teva Pharmaceuticals, Threvance; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd.) from AKL Research and Development Ltd., AstraZeneca, Boehringer Ingelheim, British Lung Foundation, Chiesi, Circassia, Mylan, Mundipharma Ltd., Napp, Novartis, Pfizer, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Teva Pharmaceuticals, Theravance, UK National Health Service, Zentiva (Sanofi Generics); payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Merck, Munipharma Ltd., Novartis, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Teva Pharmaceuticals; payment for manuscript preparation from Mundipharma Ltd., Teva Pharmaceuticals; payment for the development of educational materials from Mundipharma, Novartis; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Circassia, Mundipharma Ltd., Napp, Novartis, Teva Pharmaceuticals; funding for patient enrollment or completion of research from Chiesi, Novartis, Teva Pharmaceuticals, Zentiva (Sanofi Generics); stock/stock options from AKL Research and Development Ltd, which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 74% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); and is a peer reviewer for grant committees of the Efficacy and Mechanism Evaluation program, and Health Technology Assessment.

PY - 2019

Y1 - 2019

N2 - 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 β2-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.Abbreviations: AUCt: area under the plasma concentration-time curve from the time of dosing to the last measurable concentration; BDP: beclometasone dipropionate; BTI: breath-triggered inhaler; BUD: budesonide; CI: confidence interval; Cmax: maximum observed plasma concentration; DPI: dry powder inhaler; FDC: fixed-dose combination; FEV1: forced expiratory volume in 1 s; FORM: formoterol fumarate; FP: fluticasone propionate; HCP: health-care professional; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; OR: odds ratio; PIL: patient information leaflet; pMDI: pressurized metered-dose inhaler; SAL: salmeterol xinafoate.

AB - 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 β2-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.Abbreviations: AUCt: area under the plasma concentration-time curve from the time of dosing to the last measurable concentration; BDP: beclometasone dipropionate; BTI: breath-triggered inhaler; BUD: budesonide; CI: confidence interval; Cmax: maximum observed plasma concentration; DPI: dry powder inhaler; FDC: fixed-dose combination; FEV1: forced expiratory volume in 1 s; FORM: formoterol fumarate; FP: fluticasone propionate; HCP: health-care professional; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; OR: odds ratio; PIL: patient information leaflet; pMDI: pressurized metered-dose inhaler; SAL: salmeterol xinafoate.

KW - Asthma

KW - breath-triggered inhaler

KW - fluticasone propionate/formoterol fumarate

KW - inhaled corticosteroid/long-acting β2-agonist

KW - maintenance therapy

KW - pressurized metered-dose inhaler

U2 - 10.1080/17425247.2019.1689957

DO - 10.1080/17425247.2019.1689957

M3 - Article

C2 - 31752560

VL - 16

SP - 1367

EP - 1380

JO - Expert Opinion on Drug Delivery

JF - Expert Opinion on Drug Delivery

SN - 1742-5247

IS - 12

ER -