Real-Life Outcomes for Patients with Asthma Prescribed Spacers for Use with Either Extrafine- or Fine-Particle Inhaled Corticosteroids

Theresa W Guilbert; Gene Colice; Jonathan Grigg; Wim van Aalderen; Richard J Martin; Elliot Israel; Dirkje S Postma; Nicolas Roche; Wanda Phipatanakul; Elizabeth V Hillyer; Jennifer M Evans; Myrna B Dolovich; David B Price; Respiratory Effectiveness Group

doi:10.1016/j.jaip.2016.11.026

Real-Life Outcomes for Patients with Asthma Prescribed Spacers for Use with Either Extrafine- or Fine-Particle Inhaled Corticosteroids

Theresa W Guilbert, Gene Colice, Jonathan Grigg, Wim van Aalderen, Richard J Martin, Elliot Israel, Dirkje S Postma, Nicolas Roche, Wanda Phipatanakul, Elizabeth V Hillyer, Jennifer M Evans, Myrna B Dolovich, David B Price^* (Corresponding Author), Respiratory Effectiveness Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

14 Citations (Scopus)

Abstract

BACKGROUND: Spacers are often used with pressurized metered-dose inhalers (pMDIs) to eliminate the need for coordinating inhalation with actuation.

OBJECTIVE: To investigate the real-life effectiveness of spacers prescribed for use with either extrafine- or fine-particle inhaled corticosteroids (ICSs).

METHODS: This historical matched cohort study examined anonymous medical record data over 2 years (1-year baseline, 1-year outcome) for patients with asthma aged 12 to 80 years initiating ICSs by pMDI with or without prescribed spacer. We compared outcomes for spacer versus no-spacer arms, matched for key baseline and asthma-related characteristics, within 2 ICS cohorts: (1) extrafine-particle ICS (beclomethasone) and (2) fine-particle ICS (fluticasone). Effectiveness end points were compared using conditional regression methods.

RESULTS: Matched spacer and no-spacer arms of the extrafine-particle ICS cohort each included 2090 patients (69% females; median age, 46-47 years) and the 2 arms of the fine-particle ICS cohort each included 444 patients (67% females; median age, 45 years). With extrafine-particle ICS, we observed no significant difference between spacer and no-spacer arms in severe exacerbation rate (primary end point): adjusted rate ratio, 1.01 (95% CI, 0.83-1.23). With fine-particle ICS, the severe exacerbation rate ratio with spacers was 0.77 (0.47-1.25). Oropharyngeal candidiasis incidence was low and similar in spacer and no-spacer arms for both ICS cohorts.

CONCLUSIONS: We found no evidence that prescribed spacer devices are associated with improved asthma outcomes for extrafine- or fine-particle ICS administered by pMDI. These findings challenge long-standing assumptions that spacers should improve pMDI effectiveness and indicate the need for pragmatic trials of spacers in clinical practice.

Original language	English
Pages (from-to)	1040-1049.e4
Number of pages	14
Journal	The journal of allergy and clinical immunology. In practice
Volume	5
Issue number	4
Early online date	18 Jan 2017
DOIs	https://doi.org/10.1016/j.jaip.2016.11.026
Publication status	Published - Jul 2017

Bibliographical note

Acknowledgements
We thank Anne Burden, Vasilis Nikolaou, and Dr Alice Durieux for assistance with the analyses and Dr John Bukowski of WordsWorld Consulting for editorial assistance with the first draft of this manuscript, funded by Research in Real-Life Ltd, UK, under a subcontract by Observational and Pragmatic Research Institute Pte Ltd, Singapore. We also thank Alison Chisholm of the Respiratory Effectiveness Group for moderating the steering committee meetings at which study results were discussed.

Keywords

asthma
inhaled corticosteroid
IQR
interquartile range
MMAD
mass median aerodynamic diameter
pMDI
pressurized metered-dose inhaler
SABA
short-acting β-agonist

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Guilbert, T. W., Colice, G., Grigg, J., van Aalderen, W., Martin, R. J., Israel, E., Postma, D. S., Roche, N., Phipatanakul, W., Hillyer, E. V., Evans, J. M., Dolovich, M. B., Price, D. B., & Respiratory Effectiveness Group (2017). Real-Life Outcomes for Patients with Asthma Prescribed Spacers for Use with Either Extrafine- or Fine-Particle Inhaled Corticosteroids. The journal of allergy and clinical immunology. In practice, 5(4), 1040-1049.e4. https://doi.org/10.1016/j.jaip.2016.11.026

Guilbert, TW, Colice, G, Grigg, J, van Aalderen, W, Martin, RJ, Israel, E, Postma, DS, Roche, N, Phipatanakul, W, Hillyer, EV, Evans, JM, Dolovich, MB, Price, DB & Respiratory Effectiveness Group 2017, 'Real-Life Outcomes for Patients with Asthma Prescribed Spacers for Use with Either Extrafine- or Fine-Particle Inhaled Corticosteroids', The journal of allergy and clinical immunology. In practice, vol. 5, no. 4, pp. 1040-1049.e4. https://doi.org/10.1016/j.jaip.2016.11.026

@article{4762002f6f954f9281ba912ae6336b46,

title = "Real-Life Outcomes for Patients with Asthma Prescribed Spacers for Use with Either Extrafine- or Fine-Particle Inhaled Corticosteroids",

abstract = "BACKGROUND: Spacers are often used with pressurized metered-dose inhalers (pMDIs) to eliminate the need for coordinating inhalation with actuation.OBJECTIVE: To investigate the real-life effectiveness of spacers prescribed for use with either extrafine- or fine-particle inhaled corticosteroids (ICSs).METHODS: This historical matched cohort study examined anonymous medical record data over 2 years (1-year baseline, 1-year outcome) for patients with asthma aged 12 to 80 years initiating ICSs by pMDI with or without prescribed spacer. We compared outcomes for spacer versus no-spacer arms, matched for key baseline and asthma-related characteristics, within 2 ICS cohorts: (1) extrafine-particle ICS (beclomethasone) and (2) fine-particle ICS (fluticasone). Effectiveness end points were compared using conditional regression methods.RESULTS: Matched spacer and no-spacer arms of the extrafine-particle ICS cohort each included 2090 patients (69% females; median age, 46-47 years) and the 2 arms of the fine-particle ICS cohort each included 444 patients (67% females; median age, 45 years). With extrafine-particle ICS, we observed no significant difference between spacer and no-spacer arms in severe exacerbation rate (primary end point): adjusted rate ratio, 1.01 (95% CI, 0.83-1.23). With fine-particle ICS, the severe exacerbation rate ratio with spacers was 0.77 (0.47-1.25). Oropharyngeal candidiasis incidence was low and similar in spacer and no-spacer arms for both ICS cohorts.CONCLUSIONS: We found no evidence that prescribed spacer devices are associated with improved asthma outcomes for extrafine- or fine-particle ICS administered by pMDI. These findings challenge long-standing assumptions that spacers should improve pMDI effectiveness and indicate the need for pragmatic trials of spacers in clinical practice.",

keywords = "asthma, inhaled corticosteroid, IQR, interquartile range, MMAD, mass median aerodynamic diameter, pMDI, pressurized metered-dose inhaler, SABA, short-acting β-agonist",

author = "Guilbert, {Theresa W} and Gene Colice and Jonathan Grigg and {van Aalderen}, Wim and Martin, {Richard J} and Elliot Israel and Postma, {Dirkje S} and Nicolas Roche and Wanda Phipatanakul and Hillyer, {Elizabeth V} and Evans, {Jennifer M} and Dolovich, {Myrna B} and Price, {David B} and {Respiratory Effectiveness Group}",

note = "Acknowledgements We thank Anne Burden, Vasilis Nikolaou, and Dr Alice Durieux for assistance with the analyses and Dr John Bukowski of WordsWorld Consulting for editorial assistance with the first draft of this manuscript, funded by Research in Real-Life Ltd, UK, under a subcontract by Observational and Pragmatic Research Institute Pte Ltd, Singapore. We also thank Alison Chisholm of the Respiratory Effectiveness Group for moderating the steering committee meetings at which study results were discussed.",

year = "2017",

month = jul,

doi = "10.1016/j.jaip.2016.11.026",

language = "English",

volume = "5",

pages = "1040--1049.e4",

journal = "The journal of allergy and clinical immunology. In practice",

issn = "2213-2201",

publisher = "Elsevier",

number = "4",

}

TY - JOUR

T1 - Real-Life Outcomes for Patients with Asthma Prescribed Spacers for Use with Either Extrafine- or Fine-Particle Inhaled Corticosteroids

AU - Guilbert, Theresa W

AU - Colice, Gene

AU - Grigg, Jonathan

AU - van Aalderen, Wim

AU - Martin, Richard J

AU - Israel, Elliot

AU - Postma, Dirkje S

AU - Roche, Nicolas

AU - Phipatanakul, Wanda

AU - Hillyer, Elizabeth V

AU - Evans, Jennifer M

AU - Dolovich, Myrna B

AU - Price, David B

AU - Respiratory Effectiveness Group

N1 - Acknowledgements We thank Anne Burden, Vasilis Nikolaou, and Dr Alice Durieux for assistance with the analyses and Dr John Bukowski of WordsWorld Consulting for editorial assistance with the first draft of this manuscript, funded by Research in Real-Life Ltd, UK, under a subcontract by Observational and Pragmatic Research Institute Pte Ltd, Singapore. We also thank Alison Chisholm of the Respiratory Effectiveness Group for moderating the steering committee meetings at which study results were discussed.

PY - 2017/7

Y1 - 2017/7

N2 - BACKGROUND: Spacers are often used with pressurized metered-dose inhalers (pMDIs) to eliminate the need for coordinating inhalation with actuation.OBJECTIVE: To investigate the real-life effectiveness of spacers prescribed for use with either extrafine- or fine-particle inhaled corticosteroids (ICSs).METHODS: This historical matched cohort study examined anonymous medical record data over 2 years (1-year baseline, 1-year outcome) for patients with asthma aged 12 to 80 years initiating ICSs by pMDI with or without prescribed spacer. We compared outcomes for spacer versus no-spacer arms, matched for key baseline and asthma-related characteristics, within 2 ICS cohorts: (1) extrafine-particle ICS (beclomethasone) and (2) fine-particle ICS (fluticasone). Effectiveness end points were compared using conditional regression methods.RESULTS: Matched spacer and no-spacer arms of the extrafine-particle ICS cohort each included 2090 patients (69% females; median age, 46-47 years) and the 2 arms of the fine-particle ICS cohort each included 444 patients (67% females; median age, 45 years). With extrafine-particle ICS, we observed no significant difference between spacer and no-spacer arms in severe exacerbation rate (primary end point): adjusted rate ratio, 1.01 (95% CI, 0.83-1.23). With fine-particle ICS, the severe exacerbation rate ratio with spacers was 0.77 (0.47-1.25). Oropharyngeal candidiasis incidence was low and similar in spacer and no-spacer arms for both ICS cohorts.CONCLUSIONS: We found no evidence that prescribed spacer devices are associated with improved asthma outcomes for extrafine- or fine-particle ICS administered by pMDI. These findings challenge long-standing assumptions that spacers should improve pMDI effectiveness and indicate the need for pragmatic trials of spacers in clinical practice.

AB - BACKGROUND: Spacers are often used with pressurized metered-dose inhalers (pMDIs) to eliminate the need for coordinating inhalation with actuation.OBJECTIVE: To investigate the real-life effectiveness of spacers prescribed for use with either extrafine- or fine-particle inhaled corticosteroids (ICSs).METHODS: This historical matched cohort study examined anonymous medical record data over 2 years (1-year baseline, 1-year outcome) for patients with asthma aged 12 to 80 years initiating ICSs by pMDI with or without prescribed spacer. We compared outcomes for spacer versus no-spacer arms, matched for key baseline and asthma-related characteristics, within 2 ICS cohorts: (1) extrafine-particle ICS (beclomethasone) and (2) fine-particle ICS (fluticasone). Effectiveness end points were compared using conditional regression methods.RESULTS: Matched spacer and no-spacer arms of the extrafine-particle ICS cohort each included 2090 patients (69% females; median age, 46-47 years) and the 2 arms of the fine-particle ICS cohort each included 444 patients (67% females; median age, 45 years). With extrafine-particle ICS, we observed no significant difference between spacer and no-spacer arms in severe exacerbation rate (primary end point): adjusted rate ratio, 1.01 (95% CI, 0.83-1.23). With fine-particle ICS, the severe exacerbation rate ratio with spacers was 0.77 (0.47-1.25). Oropharyngeal candidiasis incidence was low and similar in spacer and no-spacer arms for both ICS cohorts.CONCLUSIONS: We found no evidence that prescribed spacer devices are associated with improved asthma outcomes for extrafine- or fine-particle ICS administered by pMDI. These findings challenge long-standing assumptions that spacers should improve pMDI effectiveness and indicate the need for pragmatic trials of spacers in clinical practice.

KW - asthma

KW - inhaled corticosteroid

KW - IQR

KW - interquartile range

KW - MMAD

KW - mass median aerodynamic diameter

KW - pMDI

KW - pressurized metered-dose inhaler

KW - SABA

KW - short-acting β-agonist

U2 - 10.1016/j.jaip.2016.11.026

DO - 10.1016/j.jaip.2016.11.026

M3 - Article

C2 - 28110057

SN - 2213-2201

VL - 5

SP - 1040-1049.e4

JO - The journal of allergy and clinical immunology. In practice

JF - The journal of allergy and clinical immunology. In practice

IS - 4

ER -

Real-Life Outcomes for Patients with Asthma Prescribed Spacers for Use with Either Extrafine- or Fine-Particle Inhaled Corticosteroids

Abstract

Bibliographical note

Keywords

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