Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on sleep in brain health

LIVE: Thursday 2nd May 2024, 18:00-19:30 (CEST)

Quality sleep is essential for health. But what happens to our brains when sleep patterns are disturbed? Join our experts to explore the interplay between sleep disruption and neurological diseases, and the questions that you need to be asking your patients to help you prevent the harmful effects of sleep deprivation.
ADVANCED SEARCH
Log in
Top
Respiratory Research
Published in: Respiratory Research 1/2016

Open Access 01-12-2016 | Research

Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies

Authors: François Maltais, Anne-Marie Kirsten, Alan Hamilton, Dorothy De Sousa, Florian Voß, Marc Decramer

Published in: Respiratory Research | Issue 1/2016

Login to get access

Abstract

Background

Two replicate, double-blind, placebo-controlled, 6-week crossover studies assessed the effect of the once-daily long-acting β2-agonist olodaterol 5 μg and 10 μg on constant work-rate cycle endurance in patients with moderate to very severe chronic obstructive pulmonary disease.

Methods

Patients received placebo, olodaterol 5 μg once daily (QD) and olodaterol 10 μg QD in a randomised order for 6 weeks each, with a 2-week washout period in between. The primary end point was change in endurance time during constant work-rate cycle ergometry to symptom limitation at 75 % maximal work capacity after 6 weeks of treatment (2 h post-dose), based on log10-transformed data. Key secondary end points were inspiratory capacity at isotime and intensity of breathing discomfort at isotime.

Results

151 and 157 patients were randomised and treated in Studies 1222.37 and 1222.38, respectively, with 147 and 154 being included in the full analysis sets. Mean endurance time at week 6 was increased compared to placebo by 14.0 % (Study 1222.37; p < 0.001) and 11.8 % (Study 1222.38; p < 0.01) with olodaterol 5 μg, and by 13.8 % (Study 1222.37; p < 0.001) and 10.5 % (Study 1222.38; p < 0.01) with olodaterol 10 μg. Inspiratory capacity at isotime increased with olodaterol 5 μg (Study 1222.37, 0.182 L, p < 0.0001; Study 1222.38, 0.084 L, p < 0.05) and 10 μg (Study 1222.37, 0.174 L; Study 1222.38, 0.166 L; both studies, p < 0.0001), and breathing discomfort was significantly reduced in Study 1222.37 (olodaterol 5 μg, 0.77 Borg units, p < 0.001; olodaterol 10 μg, 0.63 Borg units, p < 0.01) but not Study 1222.38.

Conclusions

These studies provide further characterisation of the efficacy of olodaterol, showing that improvements in airflow (forced expiratory volume in 1 s) are associated with increases in inspiratory capacity and improvements in exercise endurance time.

Trial registrations

NCT01040130 (1222.37) and NCT01040793 (1222.38).
Appendix
Available only for authorised users
Literature
1.
O’Donnell DE, Aaron S, Bourbeau J, Hernandez P, Marciniuk DD, Balter M, et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease – 2007 update. Can Respir J. 2007;14(Suppl B):5B–32B.
2.
Verkindre C, Bart F, Aguilaniu B, Fortin F, Guérin J-C, Le Merre C, et al. The effect of tiotropium on hyperinflation and exercise capacity in chronic obstructive pulmonary disease. Respiration. 2006;73:420–7.CrossRefPubMed
3.
O’Donnell DE. Ventilatory limitations in chronic obstructive pulmonary disease. Med Sci Sports Exerc. 2001;33(Suppl):S647–55.CrossRefPubMed
4.
O’Donnell DE, Travers J, Webb KA, He Z, Lam Y-M, Hamilton A, et al. Reliability of ventilatory parameters during cycle ergometry in multicentre trials in COPD. Eur Respir J. 2009;34:866–74.CrossRefPubMed
5.
Marin JM, Carrizo SJ, Gascon M, Sanchez A, Gallego B, Celli BR. Inspiratory capacity, dynamic hyperinflation, breathlessness, and exercise performance during the 6-minute-walk test in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001;163:1395–9.CrossRefPubMed
6.
Esteban C, Quintana JM, Aburto M, Moraza J, Egurrola M, Pérez-Izquierdo J, et al. Impact of changes in physical activity on health-related quality of life among patients with COPD. Eur Respir J. 2010;36:292–300.CrossRefPubMed
7.
Oga T, Nishimura K, Tsukino M, Sato S, Hajiro T. Analysis of the factors related to mortality in chronic obstructive pulmonary disease. Role of exercise capacity and health status. Am J Respir Crit Care Med. 2003;167:544–9.CrossRefPubMed
8.
9.
10.
O’Donnell DE, Casaburi R, Vincken W, Puente-Maestu L, Swales J, Lawrence D, et al. Effect of indacaterol on exercise endurance and lung hyperinflation in COPD. Respir Med. 2011;105:1030–6.CrossRefPubMed
11.
Liesker JJW, Wijkstra PJ, ten Hacken NHT, Koëter GH, Postma DS, Kerstjens HAM. A systematic review of the effects of bronchodilators on exercise capacity in patients with COPD. Chest. 2002;121:597–608.CrossRefPubMed
12.
O’Donnell DE, Voduc N, Fitzpatrick M, Webb KA. Effect of salmeterol on the ventilatory response to exercise in chronic obstructive pulmonary disease. Eur Respir J. 2004;24:86–94.CrossRefPubMed
13.
O’Donnell DE, Flüge T, Gerken F, Hamilton A, Webb K, Aguilaniu B, et al. Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD. Eur Respir J. 2004;23:832–40.CrossRefPubMed
14.
O’Donnell DE, Sciurba F, Celli B, Mahler DA, Webb KA, Kalberg CJ, et al. Effect of fluticasone propionate/salmeterol on lung hyperinflation and exercise endurance in COPD. Chest. 2006;130:647–56.CrossRefPubMed
15.
Maltais F, Hamilton A, Marciniuk D, Hernandez P, Sciurba FC, Richter K, et al. Improvements in symptom-limited exercise performance over 8 h with once-daily tiotropium in patients with COPD. Chest. 2005;128:1168–78.CrossRefPubMed
16.
Neder JA, Fuld JP, Overend T, Thirlwell J, Carter R, Stevenson R, et al. Effects of formoterol on exercise tolerance in severely disabled patients with COPD. Respir Med. 2007;101:2056–64.CrossRefPubMed
17.
Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, et al. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011;105:580–7.CrossRefPubMed
18.
Bouyssou T, Casarosa P, Naline E, Pestel S, Konetzki I, Devillier P, et al. Pharmacological characterization of olodaterol, a novel inhaled β 2-adrenoceptor agonist exerting a 24-hour-long duration of action in preclinical models. J Pharmacol Exp Ther. 2010;334:53–62.
19.
Casarosa P, Kollak I, Kiechle T, Ostermann A, Schnapp A, Kiesling R, et al. Functional and biochemical rationales for the 24-hour-long duration of action of olodaterol. J Pharmacol Exp Ther. 2011;337:600–9.CrossRefPubMed
20.
Joos GF, Aumann J-L, Coeck C, Korducki L, Hamilton AL, Kunz C, et al. A randomised, double-blind, four-way, crossover trial comparing the 24-h FEV1 profile for once-daily versus twice-daily treatment with olodaterol, a novel long-acting β2-agonist, in patients with chronic obstructive pulmonary disease. Respir Med. 2015;109:606–15.CrossRefPubMed
21.
Ferguson GT, Feldman GJ, Hofbauer P, Hamilton A, Allen L, Korducki L, et al. Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014;9:629–45.CrossRefPubMedPubMedCentral
22.
Koch A, Pizzichini E, Hamilton A, Hart L, Korducki L, De Salvo MC, et al. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat® versus placebo and formoterol twice daily in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014;9:697–714.CrossRefPubMedPubMedCentral
23.
Feldman GJ, Bernstein JA, Hamilton A, Nivens MC, Korducki L, LaForce C. The 24-h FEV1 time profile of olodaterol once daily via Respimat® and formoterol twice daily via Aerolizer® in patients with GOLD 2–4 COPD: results from two 6-week crossover studies. Springerplus. 2014;3:419.CrossRefPubMedPubMedCentral
24.
Lange P, Aumann J-L, Hamilton A, Tetzlaff K, Ting N, Derom E. The 24 hour lung function time profile of olodaterol once daily versus placebo and tiotropium in patients with moderate to very severe chronic obstructive pulmonary disease. J Pulm Respir Med. 2014;4:196.
25.
ERS Task Force on Standardization of Clinical Exercise Testing. Clinical exercise testing with reference to lung diseases: indications, standardization and interpretation strategies. Eur Respir J. 1997;10:2662–89.
26.
O’Donnell DE, Webb KA. Exertional breathlessness in patients with chronic airflow limitation. The role of lung hyperinflation. Am Rev Respir Dis. 1993;148:1351–7.CrossRefPubMed
27.
Coates AL, Peslin R, Rodenstein D, Stocks J. Measurement of lung volumes by plethysmography. Eur Respir J. 1997;10:1415–27.CrossRefPubMed
28.
Casaburi R, Maltais F, Porszasz J, Albers F, Deng Q, Iqbal A, et al. Effects of tiotropium on hyperinflation and treadmill exercise tolerance in mild to moderate chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014;11:1351–61.CrossRefPubMed
29.
Beeh KM, Singh D, Di Scala L, Drollmann A. Once-daily NVA237 improves exercise tolerance from the first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis. 2012;7:503–13.CrossRefPubMedPubMedCentral
30.
Borel B, Provencher S, Saey D, Maltais F. Responsiveness of various exercise-testing protocols to therapeutic interventions in COPD. Pulm Med. 2013;2013:410748.CrossRefPubMedPubMedCentral
31.
Beeh K-M, Korn S, Beier J, Jadayel D, Henley M, D’Andrea P, et al. Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study. Respir Med. 2014;108:584–92.CrossRefPubMed
32.
Cazzola M, MacNee W, Martinez FJ, Rabe KF, Franciosi LG, Barnes PJ, et al. Outcomes for COPD pharmacological trials: from lung function to biomarkers. Eur Respir J. 2008;31:416–69.CrossRefPubMed
Metadata
Title
Evaluation of the effects of olodaterol on exercise endurance in patients with chronic obstructive pulmonary disease: results from two 6-week crossover studies
Authors
François Maltais
Anne-Marie Kirsten
Alan Hamilton
Dorothy De Sousa
Florian Voß
Marc Decramer
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Respiratory Research / Issue 1/2016
Electronic ISSN: 1465-993X
DOI
https://doi.org/10.1186/s12931-016-0389-5

Other articles of this Issue 1/2016

Respiratory Research 1/2016 Go to the issue

Research

Rising total costs and mortality rates associated with admissions due to COPD exacerbations

Research

Spirometric variability in smokers: transitions in COPD diagnosis in a five-year longitudinal study

Research

Birt-Hogg-Dubé syndrome: a large single family cohort

Research

Exposure to urban PM1 in rats: development of bronchial inflammation and airway hyperresponsiveness

Erratum

Erratum to: Risk factors for mortality in patients admitted to intensive care units with pneumonia

Research

Differential DNA methylation marks and gene comethylation of COPD in African-Americans with COPD exacerbations

ACC 2024 Congress Coverage

Heart Failure Video

Year in Review: Heart failure and cardiomyopathies

Watch now

Watch this official video from ACC.24 to hear Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits