Pragmatic evaluation of inhaled corticosteroid particle size formulations on asthma control

Clin Exp Allergy. 2019 Oct;49(10):1321-1327. doi: 10.1111/cea.13453. Epub 2019 Aug 6.

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: Twenty-four 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: ClinicalTrials.gov NCT01894048.

Keywords: asthma; patient reported asthma outcomes; pharmacology; quality-of-life.

Publication types

  • Pragmatic Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adrenal Cortex Hormones / administration & dosage*
  • Adrenal Cortex Hormones / adverse effects
  • Adult
  • Aged
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Particle Size
  • Quality of Life*
  • Surveys and Questionnaires*

Substances

  • Adrenal Cortex Hormones

Associated data

  • EudraCT/2012‐003923‐39
  • ClinicalTrials.gov/NCT01894048