Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD

Peter M A Calverley, Stephen I. Rennard, Emmanuelle Clerisme-Beaty, Norbert Metzdorf, Valentina Bayer Zubek, Richard ZuWallack

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Several small studies found night-time awakenings due to COPD symptoms were associated with decreased health status. In this study, night-time awakenings in patients with COPD were examined and effects of tiotropium therapy evaluated. Methods: This study was a post hoc, exploratory, pooled analysis of twin, multicenter, double-blind, randomized, placebo-controlled, parallel-group trials. Patients with stable moderate-to-severe COPD were randomized to tiotropium HandiHaler® (n = 550) or placebo (n = 371) and followed for 13weeks. During a 2-week, pre-treatment baseline period and for 13weeks on treatment, self-reported night-time awakenings due to COPD symptoms, rescue medication (albuterol) use, and morning and evening peak expiratory flow rate (PEFR) were recorded daily. Nightly, COPD-related awakenings were scored: 0 = no awakenings; 1 = 1 awakening; 2 = 2-3 awakenings; or 3 = awake most of the night. Health-related quality-of-life (HRQoL) and energy-fatigue questionnaires were completed at baseline and during treatment. Results: Patients were aged 65.2 ± 8.7years (mean ± SD), with a mean pre-bronchodilator FEV1 of 36.1 ± 13.5% predicted normal at baseline. Data for night-time awakenings and albuterol use were available for 543 (99%) patients on tiotropium and 352 (95%) on placebo. At baseline, 280 (51.5%) patients on tiotropium and 179 (50.1%) on placebo reported ≥1 COPD-related night-time awakening per week. Over the 13-weeks' treatment, tiotropium was associated with fewer night-time awakenings, with mean ± SE overall awakening scores per week of 0.356 ± 0.006 compared with 0.421 ± 0.007 for placebo (p <0.001); means were significantly lower for tiotropium versus placebo in patients with baseline awakenings (p <0.001), but not for those without baseline awakenings. COPD-related night-time awakenings were associated with increased nocturnal rescue medication use and lower HRQoL ratings in both treatment arms. Following start of treatment, tiotropium decreased patients' use of rescue medication compared with placebo, and morning and evening adjusted means for PEFR were higher for tiotropium compared with placebo. Conclusions: Tiotropium is associated with decreased COPD-related night-time awakenings. Night-time awakenings are associated with increased nocturnal rescue medication use and may be a surrogate marker of symptom control in patients with COPD.

Original languageEnglish (US)
Article number27
JournalRespiratory Research
Volume17
Issue number1
DOIs
StatePublished - Mar 12 2016

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Chronic Obstructive Pulmonary Disease
Placebos
Peak Expiratory Flow Rate
Albuterol
Therapeutics
Quality of Life
Tiotropium Bromide
Bronchodilator Agents
Health Status
Fatigue
Biomarkers

Keywords

  • Albuterol
  • Bronchodilation
  • COPD
  • Long-acting anticholinergic
  • Night-time awakening
  • Peak expiratory flow rate
  • Rescue medication
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Calverley, P. M. A., Rennard, S. I., Clerisme-Beaty, E., Metzdorf, N., Zubek, V. B., & ZuWallack, R. (2016). Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD. Respiratory Research, 17(1), [27]. https://doi.org/10.1186/s12931-016-0340-9

Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD. / Calverley, Peter M A; Rennard, Stephen I.; Clerisme-Beaty, Emmanuelle; Metzdorf, Norbert; Zubek, Valentina Bayer; ZuWallack, Richard.

In: Respiratory Research, Vol. 17, No. 1, 27, 12.03.2016.

Research output: Contribution to journalArticle

Calverley, PMA, Rennard, SI, Clerisme-Beaty, E, Metzdorf, N, Zubek, VB & ZuWallack, R 2016, 'Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD', Respiratory Research, vol. 17, no. 1, 27. https://doi.org/10.1186/s12931-016-0340-9
Calverley PMA, Rennard SI, Clerisme-Beaty E, Metzdorf N, Zubek VB, ZuWallack R. Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD. Respiratory Research. 2016 Mar 12;17(1). 27. https://doi.org/10.1186/s12931-016-0340-9
Calverley, Peter M A ; Rennard, Stephen I. ; Clerisme-Beaty, Emmanuelle ; Metzdorf, Norbert ; Zubek, Valentina Bayer ; ZuWallack, Richard. / Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD. In: Respiratory Research. 2016 ; Vol. 17, No. 1.
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T1 - Effect of tiotropium on night-time awakening and daily rescue medication use in patients with COPD

AU - Calverley, Peter M A

AU - Rennard, Stephen I.

AU - Clerisme-Beaty, Emmanuelle

AU - Metzdorf, Norbert

AU - Zubek, Valentina Bayer

AU - ZuWallack, Richard

PY - 2016/3/12

Y1 - 2016/3/12

N2 - Background: Several small studies found night-time awakenings due to COPD symptoms were associated with decreased health status. In this study, night-time awakenings in patients with COPD were examined and effects of tiotropium therapy evaluated. Methods: This study was a post hoc, exploratory, pooled analysis of twin, multicenter, double-blind, randomized, placebo-controlled, parallel-group trials. Patients with stable moderate-to-severe COPD were randomized to tiotropium HandiHaler® (n = 550) or placebo (n = 371) and followed for 13weeks. During a 2-week, pre-treatment baseline period and for 13weeks on treatment, self-reported night-time awakenings due to COPD symptoms, rescue medication (albuterol) use, and morning and evening peak expiratory flow rate (PEFR) were recorded daily. Nightly, COPD-related awakenings were scored: 0 = no awakenings; 1 = 1 awakening; 2 = 2-3 awakenings; or 3 = awake most of the night. Health-related quality-of-life (HRQoL) and energy-fatigue questionnaires were completed at baseline and during treatment. Results: Patients were aged 65.2 ± 8.7years (mean ± SD), with a mean pre-bronchodilator FEV1 of 36.1 ± 13.5% predicted normal at baseline. Data for night-time awakenings and albuterol use were available for 543 (99%) patients on tiotropium and 352 (95%) on placebo. At baseline, 280 (51.5%) patients on tiotropium and 179 (50.1%) on placebo reported ≥1 COPD-related night-time awakening per week. Over the 13-weeks' treatment, tiotropium was associated with fewer night-time awakenings, with mean ± SE overall awakening scores per week of 0.356 ± 0.006 compared with 0.421 ± 0.007 for placebo (p <0.001); means were significantly lower for tiotropium versus placebo in patients with baseline awakenings (p <0.001), but not for those without baseline awakenings. COPD-related night-time awakenings were associated with increased nocturnal rescue medication use and lower HRQoL ratings in both treatment arms. Following start of treatment, tiotropium decreased patients' use of rescue medication compared with placebo, and morning and evening adjusted means for PEFR were higher for tiotropium compared with placebo. Conclusions: Tiotropium is associated with decreased COPD-related night-time awakenings. Night-time awakenings are associated with increased nocturnal rescue medication use and may be a surrogate marker of symptom control in patients with COPD.

AB - Background: Several small studies found night-time awakenings due to COPD symptoms were associated with decreased health status. In this study, night-time awakenings in patients with COPD were examined and effects of tiotropium therapy evaluated. Methods: This study was a post hoc, exploratory, pooled analysis of twin, multicenter, double-blind, randomized, placebo-controlled, parallel-group trials. Patients with stable moderate-to-severe COPD were randomized to tiotropium HandiHaler® (n = 550) or placebo (n = 371) and followed for 13weeks. During a 2-week, pre-treatment baseline period and for 13weeks on treatment, self-reported night-time awakenings due to COPD symptoms, rescue medication (albuterol) use, and morning and evening peak expiratory flow rate (PEFR) were recorded daily. Nightly, COPD-related awakenings were scored: 0 = no awakenings; 1 = 1 awakening; 2 = 2-3 awakenings; or 3 = awake most of the night. Health-related quality-of-life (HRQoL) and energy-fatigue questionnaires were completed at baseline and during treatment. Results: Patients were aged 65.2 ± 8.7years (mean ± SD), with a mean pre-bronchodilator FEV1 of 36.1 ± 13.5% predicted normal at baseline. Data for night-time awakenings and albuterol use were available for 543 (99%) patients on tiotropium and 352 (95%) on placebo. At baseline, 280 (51.5%) patients on tiotropium and 179 (50.1%) on placebo reported ≥1 COPD-related night-time awakening per week. Over the 13-weeks' treatment, tiotropium was associated with fewer night-time awakenings, with mean ± SE overall awakening scores per week of 0.356 ± 0.006 compared with 0.421 ± 0.007 for placebo (p <0.001); means were significantly lower for tiotropium versus placebo in patients with baseline awakenings (p <0.001), but not for those without baseline awakenings. COPD-related night-time awakenings were associated with increased nocturnal rescue medication use and lower HRQoL ratings in both treatment arms. Following start of treatment, tiotropium decreased patients' use of rescue medication compared with placebo, and morning and evening adjusted means for PEFR were higher for tiotropium compared with placebo. Conclusions: Tiotropium is associated with decreased COPD-related night-time awakenings. Night-time awakenings are associated with increased nocturnal rescue medication use and may be a surrogate marker of symptom control in patients with COPD.

KW - Albuterol

KW - Bronchodilation

KW - COPD

KW - Long-acting anticholinergic

KW - Night-time awakening

KW - Peak expiratory flow rate

KW - Rescue medication

KW - Tiotropium

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