Pragmatic evaluation of inhaled corticosteroid particle size formulations on asthma control

Chris Kuo, Sunny Jabbal, William Anderson, Brian Lipworth (Lead / Corresponding author)

Research output: Contribution to journalArticle

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Abstract

Background: Extra‐fine particle formulations of inhaled corticosteroid (ICS) are associated with improved lung delivery.

Objectives: A pragmatic study to assess patient reported outcomes after switching from fine to extra‐fine particle ICS in persistent asthma.

Methods: 24 patients (Mean age 48 year, FEV1 84%, ACQ 1.67) received 4 weeks run‐in with a constant dose of fine particle ICS (mean dose 710 μg), followed by switching to an equivalent dose of extra fine particle hydrofluoroalkane beclomethasone dipropionate (mean dose 355μg). Asthma control questionnaire (ACQ), the primary outcome, and mini asthma quality of life questionnaire (mAQLQ) were measured pre and post run‐in (baseline) and after 4 weeks and 8 weeks of switching.

Results: Comparing pre vs post run‐in there were no differences for ACQ: 1.67 vs 1.65 or AQLQ: 5.08 vs 5.34. There were mean (95%CI) improvements (P<0.001) from baseline after 8 weeks for ACQ: ‐0.53 (‐0.83, ‐0.23) and AQLQ: 0.69 (0.35, 1.04), which exceeded the minimal clinically important difference (MCID) of 0.5 for both. There were also differences (P<0.05) in domiciliary symptoms and reliever use. There were no significant changes at 8 weeks in lung function, FeNO or blood eosinophils.

Conclusions: Pragmatic switching from fine to extra‐fine particle ICS at half the dose was associated with clinically relevant improvements in asthma control and quality of life, but not lung function or type 2 biomarkers.

Trial Registration: EUDRACT (2012-003923-39) and Clintrials.gov (NCT01894048).
Original languageEnglish
Number of pages7
JournalClinical and Experimental Allergy
Early online date1 Jul 2019
DOIs
Publication statusE-pub ahead of print - 1 Jul 2019

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Particle Size
Adrenal Cortex Hormones
Asthma
HFA 134a
Lung
Quality of Life
Beclomethasone
Eosinophils
Biomarkers
Surveys and Questionnaires

Keywords

  • asthma
  • patient reported asthma outcomes
  • pharmacology
  • quality-of-life

Cite this

@article{54938e4b4d604440aeb47cabf85b0265,
title = "Pragmatic evaluation of inhaled corticosteroid particle size formulations on asthma control",
abstract = "Background: Extra‐fine particle formulations of inhaled corticosteroid (ICS) are associated with improved lung delivery.Objectives: A pragmatic study to assess patient reported outcomes after switching from fine to extra‐fine particle ICS in persistent asthma.Methods: 24 patients (Mean age 48 year, FEV1 84{\%}, ACQ 1.67) received 4 weeks run‐in with a constant dose of fine particle ICS (mean dose 710 μg), followed by switching to an equivalent dose of extra fine particle hydrofluoroalkane beclomethasone dipropionate (mean dose 355μg). Asthma control questionnaire (ACQ), the primary outcome, and mini asthma quality of life questionnaire (mAQLQ) were measured pre and post run‐in (baseline) and after 4 weeks and 8 weeks of switching.Results: Comparing pre vs post run‐in there were no differences for ACQ: 1.67 vs 1.65 or AQLQ: 5.08 vs 5.34. There were mean (95{\%}CI) improvements (P<0.001) from baseline after 8 weeks for ACQ: ‐0.53 (‐0.83, ‐0.23) and AQLQ: 0.69 (0.35, 1.04), which exceeded the minimal clinically important difference (MCID) of 0.5 for both. There were also differences (P<0.05) in domiciliary symptoms and reliever use. There were no significant changes at 8 weeks in lung function, FeNO or blood eosinophils.Conclusions: Pragmatic switching from fine to extra‐fine particle ICS at half the dose was associated with clinically relevant improvements in asthma control and quality of life, but not lung function or type 2 biomarkers.Trial Registration: EUDRACT (2012-003923-39) and Clintrials.gov (NCT01894048).",
keywords = "asthma, patient reported asthma outcomes, pharmacology, quality-of-life",
author = "Chris Kuo and Sunny Jabbal and William Anderson and Brian Lipworth",
note = "Funding: Teva Pharmaceutical Industries Ltd (Petach Tikva, Israel); University of Dundee departmental funds.",
year = "2019",
month = "7",
day = "1",
doi = "10.1111/cea.13453",
language = "English",
journal = "Clinical and Experimental Allergy",
issn = "0954-7894",
publisher = "Wiley",

}

TY - JOUR

T1 - Pragmatic evaluation of inhaled corticosteroid particle size formulations on asthma control

AU - Kuo, Chris

AU - Jabbal, Sunny

AU - Anderson, William

AU - Lipworth, Brian

N1 - Funding: Teva Pharmaceutical Industries Ltd (Petach Tikva, Israel); University of Dundee departmental funds.

PY - 2019/7/1

Y1 - 2019/7/1

N2 - Background: Extra‐fine particle formulations of inhaled corticosteroid (ICS) are associated with improved lung delivery.Objectives: A pragmatic study to assess patient reported outcomes after switching from fine to extra‐fine particle ICS in persistent asthma.Methods: 24 patients (Mean age 48 year, FEV1 84%, ACQ 1.67) received 4 weeks run‐in with a constant dose of fine particle ICS (mean dose 710 μg), followed by switching to an equivalent dose of extra fine particle hydrofluoroalkane beclomethasone dipropionate (mean dose 355μg). Asthma control questionnaire (ACQ), the primary outcome, and mini asthma quality of life questionnaire (mAQLQ) were measured pre and post run‐in (baseline) and after 4 weeks and 8 weeks of switching.Results: Comparing pre vs post run‐in there were no differences for ACQ: 1.67 vs 1.65 or AQLQ: 5.08 vs 5.34. There were mean (95%CI) improvements (P<0.001) from baseline after 8 weeks for ACQ: ‐0.53 (‐0.83, ‐0.23) and AQLQ: 0.69 (0.35, 1.04), which exceeded the minimal clinically important difference (MCID) of 0.5 for both. There were also differences (P<0.05) in domiciliary symptoms and reliever use. There were no significant changes at 8 weeks in lung function, FeNO or blood eosinophils.Conclusions: Pragmatic switching from fine to extra‐fine particle ICS at half the dose was associated with clinically relevant improvements in asthma control and quality of life, but not lung function or type 2 biomarkers.Trial Registration: EUDRACT (2012-003923-39) and Clintrials.gov (NCT01894048).

AB - Background: Extra‐fine particle formulations of inhaled corticosteroid (ICS) are associated with improved lung delivery.Objectives: A pragmatic study to assess patient reported outcomes after switching from fine to extra‐fine particle ICS in persistent asthma.Methods: 24 patients (Mean age 48 year, FEV1 84%, ACQ 1.67) received 4 weeks run‐in with a constant dose of fine particle ICS (mean dose 710 μg), followed by switching to an equivalent dose of extra fine particle hydrofluoroalkane beclomethasone dipropionate (mean dose 355μg). Asthma control questionnaire (ACQ), the primary outcome, and mini asthma quality of life questionnaire (mAQLQ) were measured pre and post run‐in (baseline) and after 4 weeks and 8 weeks of switching.Results: Comparing pre vs post run‐in there were no differences for ACQ: 1.67 vs 1.65 or AQLQ: 5.08 vs 5.34. There were mean (95%CI) improvements (P<0.001) from baseline after 8 weeks for ACQ: ‐0.53 (‐0.83, ‐0.23) and AQLQ: 0.69 (0.35, 1.04), which exceeded the minimal clinically important difference (MCID) of 0.5 for both. There were also differences (P<0.05) in domiciliary symptoms and reliever use. There were no significant changes at 8 weeks in lung function, FeNO or blood eosinophils.Conclusions: Pragmatic switching from fine to extra‐fine particle ICS at half the dose was associated with clinically relevant improvements in asthma control and quality of life, but not lung function or type 2 biomarkers.Trial Registration: EUDRACT (2012-003923-39) and Clintrials.gov (NCT01894048).

KW - asthma

KW - patient reported asthma outcomes

KW - pharmacology

KW - quality-of-life

U2 - 10.1111/cea.13453

DO - 10.1111/cea.13453

M3 - Article

C2 - 31264282

JO - Clinical and Experimental Allergy

JF - Clinical and Experimental Allergy

SN - 0954-7894

ER -