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Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR® trial.
Int J Chron Obstruct Pulmon Dis. 2018; 13:605-616.IJ

Abstract

Background

Although COPD exacerbations are known to occur more frequently in winter, there is little information on hospitalizations and cause-specific mortality. This study aimed to examine seasonal variations in mortality and exacerbations in patients with COPD during the TIOtropium Safety and Performance In Respimat® (TIOSPIR®) trial.

Patients and methods

TIOSPIR was a large-scale, multicenter trial, which assessed the safety and efficacy of tiotropium delivered via HandiHaler® (18 μg once daily) or Respimat® Soft Mist™ (2.5 or 5 μg once daily) inhaler in patients with COPD. Patients were aged ≥40 years, with a smoking history ≥10 pack-years, and post-bronchodilator forced expiratory volume in 1 second ≤70% and forced expiratory volume in 1 second/forced vital capacity ≤0.70. COPD exacerbations and deaths were monitored throughout the trial. The data were pooled to examine seasonal patterns. Southern hemisphere data were shifted by 6 months to align with northern hemisphere seasons.

Results

TIOSPIR was conducted in 43 northern (n=15,968) and 7 southern (n=1,148) hemisphere (n=1,148) countries. The median duration of treatment was 835 days, with a mean follow-up of 2.3 years. Among 19,494 exacerbations, there were clear seasonal differences (winter, 6,646 [34.1%]; spring, 4,515 [23.2%]; summer, 3,198 [16.4%]; autumn, 5,135 [26.3%]). Exacerbations peaked in early winter (December in the northern hemisphere and June in the southern hemisphere), respiratory hospitalizations in midwinter, and respiratory deaths in early spring.

Conclusion

Although winter poses a 2-fold hazard for COPD exacerbations vs summer, respiratory deaths peak in early spring. These data suggest that seasonal intensification of preventive treatments may impact COPD morbidity and mortality.

Trial registration number

NCT01126437.

Authors+Show Affiliations

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.Respiratory Medicine, University Hospital Aintree, Liverpool, UK.Biostatistics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.Clinical Development and Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.Department of Pulmonary Diseases and Critical Care Medicine, University of Texas Health Science Center and South Texas Veterans Health Care System, San Antonio, TX, USA.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29497289

Citation

Wise, Robert A., et al. "Seasonal Variations in Exacerbations and Deaths in Patients With COPD During the TIOSPIR® Trial." International Journal of Chronic Obstructive Pulmonary Disease, vol. 13, 2018, pp. 605-616.
Wise RA, Calverley PM, Carter K, et al. Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR® trial. Int J Chron Obstruct Pulmon Dis. 2018;13:605-616.
Wise, R. A., Calverley, P. M., Carter, K., Clerisme-Beaty, E., Metzdorf, N., & Anzueto, A. (2018). Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR® trial. International Journal of Chronic Obstructive Pulmonary Disease, 13, 605-616. https://doi.org/10.2147/COPD.S148393
Wise RA, et al. Seasonal Variations in Exacerbations and Deaths in Patients With COPD During the TIOSPIR® Trial. Int J Chron Obstruct Pulmon Dis. 2018;13:605-616. PubMed PMID: 29497289.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR® trial. AU - Wise,Robert A, AU - Calverley,Peter Ma, AU - Carter,Kerstine, AU - Clerisme-Beaty,Emmanuelle, AU - Metzdorf,Norbert, AU - Anzueto,Antonio, Y1 - 2018/02/14/ PY - 2018/3/3/entrez PY - 2018/3/3/pubmed PY - 2018/9/18/medline KW - HandiHaler KW - Respimat Soft Mist inhaler KW - TIOSPIR KW - exacerbations KW - preventive treatment KW - seasonality KW - tiotropium SP - 605 EP - 616 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 13 N2 - Background: Although COPD exacerbations are known to occur more frequently in winter, there is little information on hospitalizations and cause-specific mortality. This study aimed to examine seasonal variations in mortality and exacerbations in patients with COPD during the TIOtropium Safety and Performance In Respimat® (TIOSPIR®) trial. Patients and methods: TIOSPIR was a large-scale, multicenter trial, which assessed the safety and efficacy of tiotropium delivered via HandiHaler® (18 μg once daily) or Respimat® Soft Mist™ (2.5 or 5 μg once daily) inhaler in patients with COPD. Patients were aged ≥40 years, with a smoking history ≥10 pack-years, and post-bronchodilator forced expiratory volume in 1 second ≤70% and forced expiratory volume in 1 second/forced vital capacity ≤0.70. COPD exacerbations and deaths were monitored throughout the trial. The data were pooled to examine seasonal patterns. Southern hemisphere data were shifted by 6 months to align with northern hemisphere seasons. Results: TIOSPIR was conducted in 43 northern (n=15,968) and 7 southern (n=1,148) hemisphere (n=1,148) countries. The median duration of treatment was 835 days, with a mean follow-up of 2.3 years. Among 19,494 exacerbations, there were clear seasonal differences (winter, 6,646 [34.1%]; spring, 4,515 [23.2%]; summer, 3,198 [16.4%]; autumn, 5,135 [26.3%]). Exacerbations peaked in early winter (December in the northern hemisphere and June in the southern hemisphere), respiratory hospitalizations in midwinter, and respiratory deaths in early spring. Conclusion: Although winter poses a 2-fold hazard for COPD exacerbations vs summer, respiratory deaths peak in early spring. These data suggest that seasonal intensification of preventive treatments may impact COPD morbidity and mortality. Trial registration number: NCT01126437. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/29497289/Seasonal_variations_in_exacerbations_and_deaths_in_patients_with_COPD_during_the_TIOSPIR®_trial_ L2 - https://dx.doi.org/10.2147/COPD.S148393 DB - PRIME DP - Unbound Medicine ER -