Evidence map›Paper›PMID 29497289›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2018

Seasonal variations in exacerbations and deaths in patients with COPD during the TIOSPIR

Robert A Wise, Peter Ma Calverley, Kerstine Carter, Emmanuelle Clerisme-Beaty, Norbert Metzdorf, Antonio Anzueto

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01126437 (A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01126437 phase3completednot on this map

A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)

TypeinterventionalSponsorBoehringer IngelheimRan2010 to 2013Enrolled17,183ConditionsPulmonary Disease, Chronic ObstructiveArmstiotropium 18 mcg, tiotropium 1.25 mcg (2 actuations/day), tiotropium 2.5 mcg (2 actuations/day)
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Impact of a Heating Voucher on Health Outcomes in COPD Patients: A Randomised Controlled Trial.International journal of chronic obstructive pulmonary disease · 2025
    Trial
  2. Article
  3. Article
  4. Article
  5. COPD Exacerbations Before and During COVID-19 in France, Germany, Italy, the UK and the US.International journal of chronic obstructive pulmonary disease · 2024
    Article
  6. Article
  7. Article
  8. Article
  9. Observational
  10. Observational
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Robert A WiseDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Peter Ma CalverleyRespiratory Medicine, University Hospital Aintree, Liverpool, UK.
Kerstine CarterBiostatistics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Emmanuelle Clerisme-BeatyClinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Norbert MetzdorfClinical Development and Medical Affairs, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.
Antonio AnzuetoDepartment of Pulmonary Diseases and Critical Care Medicine, University of Texas Health Science Center and South Texas Veterans Health Care System, San Antonio, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 Patients and methods: TIOSPIR was a large-scale, multicenter trial, which assessed the safety and efficacy of tiotropium delivered via HandiHaler 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.

Indexed as

SeasonsAdministration, InhalationAgedBronchodilator AgentsCause of DeathCholinergic AntagonistsDisease ProgressionDouble-Blind MethodFemaleForced Expiratory VolumeHumansLungMaleMiddle AgedNebulizers and VaporizersPulmonary Disease, Chronic ObstructiveBronchodilator AgentsCholinergic AntagonistsTiotropium BromideexacerbationsHandiHalerpreventive treatmentRespimat Soft Mist inhalerseasonalityTIOSPIRtiotropium

Identifiers

PMID29497289
PMCPMC5819585

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.