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Published in: Sleep and Breathing 2/2016

01-05-2016 | Sleep Breathing Physiology and Disorders • Original Article

Tiotropium Respimat Soft Mist Inhaler versus HandiHaler to improve sleeping oxygen saturation and sleep quality in COPD

Authors: Izolde Bouloukaki, Nikolaos Tzanakis, Charalampos Mermigkis, Katerina Giannadaki, Violeta Moniaki, Eleni Mauroudi, Stylianos Michelakis, Sophia E. Schiza

Published in: Sleep and Breathing | Issue 2/2016

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Abstract

Purpose

Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. There is a shortage of data to support the efficacy of long-acting inhaled anticholinergic agents in improving these adverse effects, which are known to have a negative impact on clinical outcomes. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD.

Methods

In a randomized, open-label, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension >60 mmHg while awake), we compared the effects of 6 months’ treatment with the two devices on sleeping SaO2 and sleep quality. Overnight polysomnography and pulmonary function testing were performed at baseline and after 6 months’ treatment.

Results

A total of 188 patients completed the trial. Both groups showed significant improvement in minimum sleep SaO2 and time of sleep spent with SaO2 below 90 (TST90) compared to baseline. The patients using the Respimat had significantly better TST90 than did those using the HandiHaler. Sleep disturbance was highly variable in these patients, but the sleep stage durations were significantly better in the Respimat group.

Conclusions

Sleeping SaO2 can be improved by tiotropium delivered using either the HandiHaler device or the Respimat Soft Mist Inhaler. However, the patients who used the Respimat device had significantly better TST90 and sleep architecture parameters.
Literature
1.
go back to reference Valipour A, Lavie P, Lothaller H, Mikulic I, Burghuber OC (2011) Sleep profile and symptoms of sleep disorders in patients with stable mild to moderate chronic obstructive pulmonary disease. Sleep Med 12:367–372CrossRefPubMed Valipour A, Lavie P, Lothaller H, Mikulic I, Burghuber OC (2011) Sleep profile and symptoms of sleep disorders in patients with stable mild to moderate chronic obstructive pulmonary disease. Sleep Med 12:367–372CrossRefPubMed
3.
go back to reference Marrone O, Salvaggio A, Insalaco G (2006) Respiratory disorders during sleep in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis 1:363–372PubMedPubMedCentral Marrone O, Salvaggio A, Insalaco G (2006) Respiratory disorders during sleep in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis 1:363–372PubMedPubMedCentral
4.
go back to reference Mueller PT, Gomes MD, Viegas CA, Neder JA (2008) Systemic effects of nocturnal hypoxemia in patients with chronic obstructive pulmonary disease without obstructive sleep apnoea syndrome. J Bras Pneumol 34:567–574CrossRef Mueller PT, Gomes MD, Viegas CA, Neder JA (2008) Systemic effects of nocturnal hypoxemia in patients with chronic obstructive pulmonary disease without obstructive sleep apnoea syndrome. J Bras Pneumol 34:567–574CrossRef
5.
go back to reference Gilmartin GS, Tamisier R, Curley M, Weiss JW (2008) Ventilatory, hemodynamic, sympathetic nervous system, and vascular reactivity changes after recurrent nocturnal sustained hypoxia in humans. Am J Physiol Heart Circ Physiol 295:H778–H785CrossRefPubMedPubMedCentral Gilmartin GS, Tamisier R, Curley M, Weiss JW (2008) Ventilatory, hemodynamic, sympathetic nervous system, and vascular reactivity changes after recurrent nocturnal sustained hypoxia in humans. Am J Physiol Heart Circ Physiol 295:H778–H785CrossRefPubMedPubMedCentral
7.
go back to reference Tashkin DP, Celli B, Senn S et al (2008) A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 359:1543–1554CrossRefPubMed Tashkin DP, Celli B, Senn S et al (2008) A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 359:1543–1554CrossRefPubMed
8.
go back to reference Niewoehner DE, Rice K, Cote C, Paulson D, Cooper JA Jr, Korducki L, Cassino C, Kesten S (2005) Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med 143:317–326CrossRefPubMed Niewoehner DE, Rice K, Cote C, Paulson D, Cooper JA Jr, Korducki L, Cassino C, Kesten S (2005) Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med 143:317–326CrossRefPubMed
9.
go back to reference O’Donnell DE, Flüge T, Gerken F, Hamilton A, Webb K, Aguilaniu B, Make B, Magnussen H (2004) Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J 23:832–840CrossRefPubMed O’Donnell DE, Flüge T, Gerken F, Hamilton A, Webb K, Aguilaniu B, Make B, Magnussen H (2004) Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J 23:832–840CrossRefPubMed
10.
go back to reference Tsai SC, Lee-Chiong T (2009) Lung hyperinflation and sleep quality in the overlap syndrome. COPD 6:419–420CrossRefPubMed Tsai SC, Lee-Chiong T (2009) Lung hyperinflation and sleep quality in the overlap syndrome. COPD 6:419–420CrossRefPubMed
11.
go back to reference Kwon JS, Wolfe LF, Lu BS, Kalhan R (2009) Hyperinflation is associated with lower sleep efficiency in COPD with co-existent obstructive sleep apnea. COPD 6:441–445CrossRefPubMed Kwon JS, Wolfe LF, Lu BS, Kalhan R (2009) Hyperinflation is associated with lower sleep efficiency in COPD with co-existent obstructive sleep apnea. COPD 6:441–445CrossRefPubMed
12.
go back to reference McNicholas WT, Calverley PM, Lee A, Edwards JC (2004) Tiotropium Sleep Study in COPD Investigators. Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD. Eur Respir J 23:825–831CrossRefPubMed McNicholas WT, Calverley PM, Lee A, Edwards JC (2004) Tiotropium Sleep Study in COPD Investigators. Long-acting inhaled anticholinergic therapy improves sleeping oxygen saturation in COPD. Eur Respir J 23:825–831CrossRefPubMed
13.
go back to reference Wise RA, Anzueto A, Cotton D et al (2013) Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med 369:1491–1501CrossRefPubMed Wise RA, Anzueto A, Cotton D et al (2013) Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med 369:1491–1501CrossRefPubMed
15.
go back to reference Johns MW (1991) A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 14:540–545PubMed Johns MW (1991) A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 14:540–545PubMed
16.
go back to reference American Thoracic Society (1995) Standardization of spirometry, 1994 update. Am J Respir Crit Care Med 152:1107–1136CrossRef American Thoracic Society (1995) Standardization of spirometry, 1994 update. Am J Respir Crit Care Med 152:1107–1136CrossRef
17.
go back to reference Iber K, Ancoli-Israel S, Chesson AL, Quan SF (2007) The AASM Manual for the scoring of sleep and associated events. American Academy of Sleep Medicine, Westchester Iber K, Ancoli-Israel S, Chesson AL, Quan SF (2007) The AASM Manual for the scoring of sleep and associated events. American Academy of Sleep Medicine, Westchester
18.
go back to reference Sanders MH, Newman AB, Haggerty CL, Redline S, Lebowitz M, Samet J, O'Connor GT, Punjabi NM, Shahar E, Sleep Heart Health Study (2003) Sleep and sleep-disordered breathing in adults with predominantly mild obstructive airway disease. Am J Respir Crit Care Med 167:7–14CrossRefPubMed Sanders MH, Newman AB, Haggerty CL, Redline S, Lebowitz M, Samet J, O'Connor GT, Punjabi NM, Shahar E, Sleep Heart Health Study (2003) Sleep and sleep-disordered breathing in adults with predominantly mild obstructive airway disease. Am J Respir Crit Care Med 167:7–14CrossRefPubMed
19.
go back to reference Catterall JR, Douglas NJ, Calverley PM, Shapiro CM, Brezinova V, Brash HM, Flenley DC (1983) Transient hypoxemia during sleep in chronic obstructive pulmonary disease is not a sleep apnea syndrome. Am Rev Respir Dis 128:24–29CrossRefPubMed Catterall JR, Douglas NJ, Calverley PM, Shapiro CM, Brezinova V, Brash HM, Flenley DC (1983) Transient hypoxemia during sleep in chronic obstructive pulmonary disease is not a sleep apnea syndrome. Am Rev Respir Dis 128:24–29CrossRefPubMed
20.
go back to reference Douglas NJ (1992) Nocturnal hypoxemia in patients with chronic obstructive pulmonary disease. Clin Chest Med 13:523–532PubMed Douglas NJ (1992) Nocturnal hypoxemia in patients with chronic obstructive pulmonary disease. Clin Chest Med 13:523–532PubMed
21.
go back to reference Postma DS, Keyzer JJ, Koëter GH, Sluiter HJ, De Vries K (1985) Influence of the parasympathetic nervous system on nocturnal bronchial obstruction. Clin Sci 69:251–258CrossRefPubMed Postma DS, Keyzer JJ, Koëter GH, Sluiter HJ, De Vries K (1985) Influence of the parasympathetic nervous system on nocturnal bronchial obstruction. Clin Sci 69:251–258CrossRefPubMed
22.
go back to reference Calverley PM, Lee A, Towse L, van Noord J, Witek TJ, Kelsen S (2003) Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease. Thorax 58:855–860CrossRefPubMedPubMedCentral Calverley PM, Lee A, Towse L, van Noord J, Witek TJ, Kelsen S (2003) Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease. Thorax 58:855–860CrossRefPubMedPubMedCentral
23.
go back to reference Martin RJ, Bartelson BL, Smith P, Hudgel DW, Lewis D, Pohl G, Koker P, Souhrada JF (1999) Effect of ipratropium bromide treatment on oxygen saturation and sleep quality in COPD. Chest 115:1525–1532CrossRef Martin RJ, Bartelson BL, Smith P, Hudgel DW, Lewis D, Pohl G, Koker P, Souhrada JF (1999) Effect of ipratropium bromide treatment on oxygen saturation and sleep quality in COPD. Chest 115:1525–1532CrossRef
24.
go back to reference Sposato B, Franco C (2008) Short term effect of a single dose of formoterol or tiotropium on the isolated nocturnal hypoxemia in stable COPD patients: a double blind randomized study. Eur Rev Med Pharmacol Sci 12:203–211PubMed Sposato B, Franco C (2008) Short term effect of a single dose of formoterol or tiotropium on the isolated nocturnal hypoxemia in stable COPD patients: a double blind randomized study. Eur Rev Med Pharmacol Sci 12:203–211PubMed
25.
go back to reference McNicholas WT (2006) Sleep in chronic obstructive pulmonary disease. Eur Respir Mon 38:325–336 McNicholas WT (2006) Sleep in chronic obstructive pulmonary disease. Eur Respir Mon 38:325–336
26.
go back to reference Boselli M, Parrino L, Smerieri A, Terzano MG (1998) Effect of age on EEG arousals in normal sleep. Sleep 21:351–357PubMed Boselli M, Parrino L, Smerieri A, Terzano MG (1998) Effect of age on EEG arousals in normal sleep. Sleep 21:351–357PubMed
27.
go back to reference Mermigkis C, Kopanakis A, Foldvary-Schaefer N, Golish J, Polychronopoulos V, Schiza S, Amfilochiou A, Siafakas N, Bouros D (2007) Health-related quality of life in patients with obstructive sleep apnoea and chronic obstructive pulmonary disease (overlap syndrome). Int J Clin Pract 61:207–211CrossRefPubMed Mermigkis C, Kopanakis A, Foldvary-Schaefer N, Golish J, Polychronopoulos V, Schiza S, Amfilochiou A, Siafakas N, Bouros D (2007) Health-related quality of life in patients with obstructive sleep apnoea and chronic obstructive pulmonary disease (overlap syndrome). Int J Clin Pract 61:207–211CrossRefPubMed
28.
go back to reference Fleetham J, West P, Mezon B, Conway W, Roth T, Kryger M (1982) Sleep, arousals, and oxygen desaturation in chronic obstructive pulmonary disease: the effect of oxygen therapy. Am Rev Respir Dis 126:429–433PubMed Fleetham J, West P, Mezon B, Conway W, Roth T, Kryger M (1982) Sleep, arousals, and oxygen desaturation in chronic obstructive pulmonary disease: the effect of oxygen therapy. Am Rev Respir Dis 126:429–433PubMed
29.
go back to reference Calverley PM, Brezinova V, Douglas NJ, Catterall JR, Flenley DC (1982) The effect of oxygenation on sleep quality in chronic bronchitis and emphysema. Am Rev Respir Dis 126:206–210PubMed Calverley PM, Brezinova V, Douglas NJ, Catterall JR, Flenley DC (1982) The effect of oxygenation on sleep quality in chronic bronchitis and emphysema. Am Rev Respir Dis 126:206–210PubMed
30.
go back to reference Lewis CA, Fergusson W, Eaton T, Zeng I, Kolbe J (2009) Isolated nocturnal desaturation in COPD: prevalence and impact on quality of life and sleep. Thorax 64:133–138CrossRefPubMed Lewis CA, Fergusson W, Eaton T, Zeng I, Kolbe J (2009) Isolated nocturnal desaturation in COPD: prevalence and impact on quality of life and sleep. Thorax 64:133–138CrossRefPubMed
31.
go back to reference McNicholas WT, Verbraecken J, Marin JM (2013) Sleep disorders in COPD: the forgotten dimension. Eur Respir Rev 22:365–375CrossRefPubMed McNicholas WT, Verbraecken J, Marin JM (2013) Sleep disorders in COPD: the forgotten dimension. Eur Respir Rev 22:365–375CrossRefPubMed
32.
go back to reference Nunes DM, Mota RM, de Pontes Neto OL, Pereira ED, de Bruin VM, de Bruin PF (2009) Impaired sleep reduces quality of life in chronic obstructive pulmonary disease. Lung 187:159–163CrossRefPubMed Nunes DM, Mota RM, de Pontes Neto OL, Pereira ED, de Bruin VM, de Bruin PF (2009) Impaired sleep reduces quality of life in chronic obstructive pulmonary disease. Lung 187:159–163CrossRefPubMed
33.
go back to reference Omachi TA, Blanc PD, Claman DM, Chen H, Yelin EH, Julian L, Katz PP (2012) Disturbed sleep among COPD patients is longitudinally associated with mortality and adverse COPD outcomes. Sleep Med 13:476–483CrossRefPubMedPubMedCentral Omachi TA, Blanc PD, Claman DM, Chen H, Yelin EH, Julian L, Katz PP (2012) Disturbed sleep among COPD patients is longitudinally associated with mortality and adverse COPD outcomes. Sleep Med 13:476–483CrossRefPubMedPubMedCentral
34.
go back to reference Fletcher EC, Miller J, Divine GW, Fletcher JG, Miller T (1987) Nocturnal oxyhemoglobin desaturation in COPD patients with arterial oxygen tensions above 60 mm Hg. Chest 92:604–608CrossRefPubMed Fletcher EC, Miller J, Divine GW, Fletcher JG, Miller T (1987) Nocturnal oxyhemoglobin desaturation in COPD patients with arterial oxygen tensions above 60 mm Hg. Chest 92:604–608CrossRefPubMed
35.
go back to reference Dalby R, Spallek M, Voshaar T (2004) A review of the development of respimat soft mist inhaler. Int J Pharm 283:1–9CrossRefPubMed Dalby R, Spallek M, Voshaar T (2004) A review of the development of respimat soft mist inhaler. Int J Pharm 283:1–9CrossRefPubMed
36.
go back to reference Beeh KM, Beier J, Donohue JF (2012) Clinical trial design in chronic obstructive pulmonary disease: current perspectives and considerations with regard to blinding of tiotropium. Respir Res 13:52CrossRefPubMedPubMedCentral Beeh KM, Beier J, Donohue JF (2012) Clinical trial design in chronic obstructive pulmonary disease: current perspectives and considerations with regard to blinding of tiotropium. Respir Res 13:52CrossRefPubMedPubMedCentral
Metadata
Title
Tiotropium Respimat Soft Mist Inhaler versus HandiHaler to improve sleeping oxygen saturation and sleep quality in COPD
Authors
Izolde Bouloukaki
Nikolaos Tzanakis
Charalampos Mermigkis
Katerina Giannadaki
Violeta Moniaki
Eleni Mauroudi
Stylianos Michelakis
Sophia E. Schiza
Publication date
01-05-2016
Publisher
Springer Berlin Heidelberg
Published in
Sleep and Breathing / Issue 2/2016
Print ISSN: 1520-9512
Electronic ISSN: 1522-1709
DOI
https://doi.org/10.1007/s11325-015-1259-y

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