The DOI matches its Crossref record; 29 of the 29 references it cites were found in a registry or an index.
Once-Daily Bronchodilators for Chronic Obstructive Pulmonary Disease: Indacaterol Versus Tiotropium
Abstract
RATIONALE: Indacaterol is the first once-daily, long-acting inhaled beta(2)-agonist bronchodilator studied in patients with chronic obstructive pulmonary disease (COPD). OBJECTIVES: To demonstrate greater efficacy of indacaterol versus placebo on FEV(1) at 24 hours post dose (trough) after 12 weeks, to compare efficacy with placebo and tiotropium, and to evaluate safety and tolerability over 26 weeks. MEASUREMENTS: Patients with moderate-to-severe COPD were randomized to double-blind indacaterol 150 or 300 microg or placebo, or open-label tiotropium 18 microg, all once daily, for 26 weeks. The primary efficacy outcome was trough FEV(1) at 12 weeks. Additional analyses (not adjusted for multiplicity) included transition dyspnea index (TDI), health status (St George's Respiratory Questionnaire [SGRQ]), and exacerbations. Serum potassium, blood glucose, and QTc interval were measured. RESULTS: A total of 1,683 patients (age, 63.3 yr; post-bronchodilator FEV(1), 56% predicted; FEV(1)/FVC, 0.53) were randomized to the four treatment arms. Trough FEV(1) at Week 12 increased versus placebo by 180 ml with both indacaterol doses and by 140 ml with tiotropium (all P < 0.001 vs. placebo). At Week 26, for indacaterol 150/300 microg, respectively, versus placebo, TDI increased (1.00/1.18, P < 0.001) and SGRQ total score decreased (-3.3/-2.4, P < 0.01); corresponding results with tiotropium were 0.87 (P < 0.001) for TDI and (-1.0, P = not significant) for SGRQ total score. The incidence of adverse events, low serum potassium, high blood glucose, and prolonged QTc interval was similar across treatments. CONCLUSIONS: Indacaterol was an effective once-daily bronchodilator and was at least as effective as tiotropium in improving clinical outcomes for patients with COPD. Clinical trial registered with clinicaltrials.gov (NCT 00463567).
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Citations
Cites
Miller, M. R., Hankinson, J., Brusasco, V., Burgos, F., Casaburi, R., Coates, A., Crapo, R., Enright, P., van der Grinten, C. P. M., Gustafsson, P., et al. (2005) · European Respiratory Journal · doi:10.1183/09031936.05.00034805 · Cited by 15,627
Salmeterol and Fluticasone Propionate and Survival in Chronic Obstructive Pulmonary Disease
Calverley, P. M. A., Anderson, J. A., Celli, B., Ferguson, G. T., Jenkins, C., Jones, P. W., Yates, J. C., & Vestbo, J. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa063070 · Cited by 3,248
Jones, P. W., Quirk, F. H., Baveystock, C. M., & Littlejohns, P. (1992) · American Review of Respiratory Disease · doi:10.1164/ajrccm/145.6.1321 · Cited by 3,035 · cited 1×
“Dyspnea was assessed with the transition dyspnea index (TDI) [20], and health status with the St George’s Respiratory Questionnaire (SGRQ) [21].”
MethodThe St George's Respiratory Questionnaire
Jones, P. W., Quirk, F. H., & Baveystock, C. M. (1991) · Respiratory Medicine · doi:10.1016/s0954-6111(06)80166-6 · Cited by 2,683
A 4-Year Trial of Tiotropium in Chronic Obstructive Pulmonary Disease
Tashkin, D. P., Celli, B., Senn, S., Burkhart, D., Kesten, S., Menjoge, S., & Decramer, M. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0805800 · Cited by 1,604
Mahler, D. A., Weinberg, D. H., Wells, C. K., & Feinstein, A. R. (1984) · Chest · doi:10.1378/chest.85.6.751 · Cited by 1,292
Self-citationA long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease
Casaburi, R., Mahler, D. A., Jones, P. W., Wanner, A., San Pedro, G., ZuWallack, R. L., Menjoge, S. S., Serby, C. W., & Witek, T. (2002) · European Respiratory Journal · doi:10.1183/09031936.02.00269802 · Cited by 881
Self-citationOutcomes for COPD pharmacological trials: from lung function to biomarkers
Cazzola, M., MacNee, W., Martinez, F. J., Rabe, K. F., Franciosi, L. G., Barnes, P. J., Brusasco, V., Burge, P. S., Calverley, P. M. A., Celli, B. R., et al. (2008) · European Respiratory Journal · doi:10.1183/09031936.00099306 · Cited by 858
Self-citationSt. George's Respiratory Questionnaire: MCID
Jones, P. W. (2005) · COPD: Journal of Chronic Obstructive Pulmonary Disease · doi:10.1081/copd-200050513 · Cited by 855
Minimal Clinically Important Differences in COPD Lung Function
Donohue, J. F. (2005) · COPD: Journal of Chronic Obstructive Pulmonary Disease · doi:10.1081/copd-200053377 · Cited by 529
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Cited by
Adaptive Designs for Clinical Trials
Bhatt, D. L., & Mehta, C. (2016) · New England Journal of Medicine · doi:10.1056/nejmra1510061 · Cited by 499
Dimairo, M., Pallmann, P., Wason, J., Todd, S., Jaki, T., Julious, S. A., Mander, A. P., Weir, C. J., Koenig, F., Walton, M. K., et al. (2020) · Trials · doi:10.1186/s13063-020-04334-x · Cited by 58
Longitudinal Changes in Patient-reported Dyspnea in Patients with COPD
Mahler, D. A., Ward, J., Waterman, L. A., & Baird, J. C. (2012) · COPD: Journal of Chronic Obstructive Pulmonary Disease · doi:10.3109/15412555.2012.701678 · Cited by 27
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Metadata
- Authors
- Donohue, J. F., Fogarty, C., Lötvall, J., Mahler, D. A., Worth, H., Yorgancioğlu, A., Iqbal, A., Swales, J., Owen, R., Higgins, M., & Kramer, B.
- Venue
- American Journal of Respiratory and Critical Care Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-07-15
- Volume
- 182
- Issue
- 2
- Pages
- 155-162
- ISSN
- 1073-449X (ISSN-L)
- 1535-4970
- OpenAlex
- W2125779455
- Cited by
- 358
- References
- 29
- FWCI
- 41.08
- Type
- journal article
- Language
- en
- Open access
- closed
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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