Evidence map›Paper›PMID 24841833›Full record

Trial reportNPJ primary care respiratory medicine2014

Tiotropium in patients with moderate COPD naive to maintenance therapy: a randomised placebo-controlled trial.

Thierry Troosters, Frank C Sciurba, Marc Decramer, Nikos M Siafakas, Solomon S Klioze, Santosh C Sutradhar, Idelle M Weisman, Carla Yunis

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in NPJ primary care respiratory medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 7 pooled it
9.4field-weighted citation impact, top 2% of its field
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

33 citing papers in PubMed, 7 syntheses or guidelines pooled it, 73 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 3 countries.

Thierry TroostersDepartment of Rehabilitation Sciences and Respiratory Division UZ Leuven, Katholieke Universiteit Leuven, Leuven, Belgium.
Frank C SciurbaEmphysema Research Center, Division of Pulmonary and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Marc DecramerPneumology, Katholieke Universiteit Leuven and University Hospitals Leuven, Leuven, Belgium.
Nikos M SiafakasUniversity Hospital of Heraklion, Heraklion, Greece.
Solomon S KliozePfizer, Groton, CT, USA.
Santosh C SutradharPfizer, New York, NY, USA.
Idelle M WeismanPfizer, New York, NY, USA.
Carla YunisPfizer, New York, NY, USA.
Pfizer (United States) · USKU Leuven · BEUniversity Hospital of Heraklion · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe benefits of pharmacotherapy with tiotropium HandiHaler 18 μg for patients with chronic obstructive pulmonary disease (COPD) have been previously demonstrated. However, few data exist regarding the treatment of moderate disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II).

aimsTo determine whether tiotropium improves lung function/patient-reported outcomes in patients with GOLD stage II COPD naive to maintenance therapy.

methodsA randomised 24-week double-blind placebo-controlled trial of tiotropium 18 μg once daily (via HandiHaler) was performed in maintenance therapy-naive patients with forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio <0.7 and post-bronchodilator FEV1 ≥50 and <80%.

resultsA total of 457 patients were randomised (238 tiotropium, 219 placebo; mean age 62 years; FEV1 1.93 l (66% predicted)). Tiotropium was superior to placebo in mean change from baseline in post-dose FEV1 area under the curve from 0 to 3 h (AUC0-3h) at week 24 (primary endpoint): 0.19 vs. -0.03 l (least-squares mean difference 0.23 l, P<0.001). FVC AUC0-3h, trough and peak FEV1 and FVC were significantly improved with tiotropium versus placebo (P<0.001). Compared with placebo, tiotropium provided numerical improvements in physical activity (P=NS). Physician's Global Assessment (health status) improved (P=0.045) with less impairment on the Work Productivity and Activity Impairment questionnaire (P=0.043) at week 24. The incidence of exacerbations, cough, bronchitis and dyspnoea was lower with tiotropium than placebo.

conclusionsTiotropium improved lung function and patient-reported outcomes in maintenance therapy-naive patients with GOLD stage II COPD, suggesting benefits in initiating maintenance therapy early.

Indexed as

Activities of Daily LivingBronchodilator AgentsDouble-Blind MethodFemaleForced Expiratory VolumeHealth StatusHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveScopolamine DerivativesSeverity of Illness IndexTiotropium BromideTreatment OutcomeBronchodilator AgentsScopolamine DerivativesTiotropium Bromide

Identifiers

PMID24841833
PMCPMC4373257
OpenAlexW1972190609

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.