Daily home-based spirometry during withdrawal of inhaled corticosteroid in severe to very severe chronic obstructive pulmonary disease

Abstract

The WISDOM study (NCT0975195) reported a change in lung function following withdrawal of fluticasone propionate in patients with severe to very severe COPD treated with tiotropium and salmeterol. However, little is known about the validity of home-based spirometry measurements of lung function in COPD. Therefore, as part of this study, following suitable training, patients recorded daily home-based spirometry measurements in addition to undergoing periodic in-clinic spirometric testing throughout the study duration. We subsequently determined the validity of home-based spirometry for detecting changes in lung function by comparing in-clinic and home-based forced expiratory volume in 1 second in patients who underwent stepwise fluticasone propionate withdrawal over 12 weeks versus patients remaining on fluticasone propionate for 52 weeks. Bland–Altman analysis of these data confirmed good agreement between in-clinic and home-based measurements, both across all visits and at the individual visits at study weeks 6, 12, 18, and 52. There was a measurable difference between the forced expiratory volume in 1 second values recorded at home and in the clinic (mean difference of −0.05 L), which may be due to suboptimal patient effort in performing unsupervised recordings. However, this difference remained consistent over time. Overall, these data demonstrate that home-based and in-clinic spirometric measurements were equally valid and reliable for assessing lung function in patients with COPD, and suggest that home-based spirometry may be a useful tool to facilitate analysis of changes in lung function on a day-to-day basis.

Keywords:

• FEV₁
• home-based spirometry
• inhaled corticosteroid
• lung function
• severe COPD

Acknowledgments

This work was supported by Boehringer Ingelheim Pharma GmbH & Co. KG. Medical writing assistance was provided by Marshall Naden, PhD, of Complete HealthVizion, which was contracted and compensated by Boehringer Ingelheim Pharma GmbH & Co. KG.

Disclosures

RR-R reports grants from Almirall and Menarini, and personal fees for advisory boards and lectures from Astra-Zeneca, Boehringer Ingelheim, Mylan, Takeda, Pearl Therapeutics, Teva, Almirall, Ferrer, Menarini, and Novartis outside of the submitted work. KT is an employee of, BD is a former employee of and HF is contracted to, Boehringer Ingelheim. HW reports consulting fees and compensation for his institution during the conduct of the study from Boehringer Ingelheim related to the submitted work, and participation in advisory boards for Almirall, AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline, in lectures for Almirall, AstraZeneca, Boehringer Ingelheim, Berlin-Chemie, GlaxoSmithKline, Novartis, and Chiesi, and congress travel support from GlaxoSmithKline and Novartis outside of the submitted work. His institution has also received compensation for the conduct of clinical studies from Almirall, AstraZeneca, Boehringer Ingelheim, Glaxo-SmithKline, Novartis, Chiesi, Takeda, AB2 Bio, Bayer, and InterMune outside of the submitted work. EFMW reports grants and personal fees from AstraZeneca, Glaxo-SmithKline, and Novartis, and personal fees from Takeda, Pfizer, and Boehringer Ingelheim outside of the submitted work. HM reports consulting fees and compensation for his institution during the conduct of the study from Boehringer Ingelheim related to the submitted work, and participation in advisory boards for Almirall, AstraZeneca, Boehringer Ingelheim, Berlin-Chemie, and Novartis, and in lectures for Almirall, AstraZeneca, Boehringer Ingelheim, Berlin-Chemie, Novartis, and Chiesi outside of the submitted work. His institution has also received compensation for the conduct of clinical studies from Almirall, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Chiesi, Takeda, AB2 Bio, Bayer, and InterMune outside of the submitted work. PMAC reports a study grant from Boehringer Ingelheim related to the submitted work, and a grant from GlaxoSmithKline and speaker fees and consultancy for AstraZeneca, Takeda, and Boehringer Ingelheim outside of the submitted work. The authors report no other conflicts of interest in this work.

Author contributions

All authors contributed toward data analysis and interpretation, drafting and revising the paper and agree to be accountable for all aspects of the work.