Evidence map›Paper›PMID 18488436›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2008

Improvement in self-reported exercise participation with the combination of tiotropium and rehabilitative exercise training in COPD patients.

Steven Kesten, Richard Casaburi, David Kukafka, Christopher B Cooper

3 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
–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.

NCT03084718 phase2completednot on this mapstarted 2017, after this paper: background citation

An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled610ConditionsAsthmaArmsCHF 718 pMDI, Placebo pMDI, Beclomethasone Dipropionate (BDP)
NCT03084796 phase2completednot on this mapstarted 2017, after this paper: background citation

A 6-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI (HFA Glycopyrronium Bromide Via Pressurized Metered Dose Inhaler) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled733ConditionsCOPD, Chronic Obstructive Pulmonary DiseaseArmsCHF 5259, Placebo, Tiotropium Bromide 18 µg Inhalation Capsule
NCT03086460 phase2completednot on this mapstarted 2017, after this paper: background citation

A Randomized, Double-blind, Placebo and Active-controlled, Incomplete Block Cross-over, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 1531 pMDI (Formoterol Fumarate) in Asthmatic Subjects

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled67ConditionsAsthmaArmsCHF 1531 pMDI, Formoterol Inhalation Solution, Placebo pMDI
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Tiotropium versus placebo for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2014
    Pooled it
  4. Trial
  5. Trial
  6. Tiotropium and exercise training in COPD patients: effects on dyspnea and exercise tolerance.International journal of chronic obstructive pulmonary disease · 2008
    Trial
  7. Review
  8. Article
  9. Review
  10. Review
  11. Observational
  12. Article
  13. Profile of a fixed-dose combination of tiotropium/olodaterol and its potential in the treatment of COPD.International journal of chronic obstructive pulmonary disease · 2015
    Review
  14. Pulmonary rehabilitation and COPD: providing patients a good environment for optimizing therapy.International journal of chronic obstructive pulmonary disease · 2014
    Review
  15. Article
  16. Review
  17. Observational
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Steven KestenBoehringer Ingelheim GmbH, Ingelheim, Germany. ; 2Harbor-UCLA Medical Center, Torrance, CA, USA. skesten@ing.boehringer-ingelheim.com
Richard Casaburi
David Kukafka
Christopher B Cooper

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImprovements in ventilatory mechanics with tiotropium increases exercise tolerance during pulmonary rehabilitation. We wondered whether tiotropium also increased physical activities outside of pulmonary rehabilitation.

methodsCOPD patients participating in 8 weeks of pulmonary rehabilitation were studied in a randomized, double-blind, placebo-controlled trial of tiotropium 18 microg daily (tiotropium = 47, placebo = 44). Study drug was administered for 5 weeks prior to, 8 weeks during, and 12 weeks following pulmonary rehabilitation. Patients completed a questionnaire documenting participation in pre-defined activities outside ofpulmonary rehabilitation during the 2 weeks prior to each visit. Patients who submitted an activity questionnaire at week 4 and on at least one subsequent visit were included in the analysis. For each patient, the number of sessions was multiplied with the duration of each activity and then summed to give overall activity duration.

resultsPatients (n = 46) had mean age of 67 years, mean baseline FEVJ of 0.84 L (33% predicted). Mean (SE) increase in duration of activities (minutes during 2 weeks prior to each visit) from week 4 (prior to PR) to week 13 (end of PR) was 145 (84) minutes with tiotropium and 66 (96) minutes with placebo. The increase from week 4 to week 25 (end of follow-up) was 262 (96) and 60 (93) minutes for the respective groups. Increases in activity duration from week 4 to weeks 17, 21, and 25 were statistically significant with tiotropium. No statistical differences over time were observed within the placebo-treated group and differences between groups were not significant.

conclusionsTiotropium appears to amplify the effectiveness of pulmonary rehabilitation as seen by increases in patient self-reported participation in physical activities.

Indexed as

ExerciseHealth BehaviorAgedBronchodilator AgentsDouble-Blind MethodExercise ToleranceFemaleFollow-Up StudiesForced Expiratory VolumeHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveScopolamine DerivativesSelf-AssessmentTiotropium BromideBronchodilator AgentsScopolamine DerivativesTiotropium Bromide

Identifiers

PMID18488436
PMCPMC2528216

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.