Evidence map›Paper›PMID 20714373›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2010

Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies.

Eric Bateman, Dave Singh, David Smith, Bernd Disse, Lesley Towse, Dan Massey, Jon Blatchford, Demetri Pavia, Rick Hodder

Abstract readRandomized Controlled Trial
PubMed Full text at PMC
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 12 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 12 syntheses or guidelines pooled it.

  1. Efficacy and cardiovascular safety of LAMA in patients with COPD: a systematic review and meta-analysis.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2021
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  7. Tiotropium versus placebo for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2014
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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

9 authors.

Eric BatemanDivision of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Dave Singh
David Smith
Bernd Disse
Lesley Towse
Dan Massey
Jon Blatchford
Demetri Pavia
Rick Hodder

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Two 1-year studies evaluated the long-term efficacy and safety of tiotropium 5 or 10 microg versus placebo, inhaled via the Respimat Soft Mist Inhaler (SMI). The two studies were combined and had 4 co-primary endpoints (trough FEV(1) response, Mahler Transition Dyspnea Index [TDI] and St George's Respiratory Questionnaire scores all at week 48, and COPD exacerbations per patient-year). A total of 1990 patients with COPD participated (mean FEV(1): 1.09 L). The mean trough FEV(1) response of tiotropium 5 or 10 microg relative to placebo was 127 or 150 mL, respectively (both P < 0.0001). The COPD exacerbation rate was significantly lower with tiotropium 5 microg (RR = 0.78; P = 0.002) and tiotropium 10 microg (RR = 0.73; P = 0.0008); the health-related quality of life and Mahler TDI co-primary endpoints were significantly improved with both doses (both P < 0.0001). Adverse events were generally balanced except anticholinergic class effects, which were more frequent with active treatment. Fatal events occurred in 2.4% (5 microg), 2.7% (10 microg), and 1.6% (placebo) of patients; these differences were not significant. Tiotropium Respimat SMI 5 microg demonstrated sustained improvements in patients with COPD relative to placebo and similar to the 10 microg dose but with a lower frequency of anticholinergic adverse events.

Indexed as

Administration, InhalationAgedBronchodilator AgentsFemaleForced Expiratory VolumeHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuality of LifeScopolamine DerivativesSurveys and QuestionnairesTiotropium BromideTreatment OutcomeBronchodilator AgentsScopolamine DerivativesTiotropium BromideCOPDexacerbationsFEV1quality of lifeRespimat®tiotropium

Identifiers

PMID20714373
PMCPMC2921687

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.