Evidence map›Paper›PMID 34511891›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

TRONARTO: A Randomized, Placebo-Controlled Study of Tiotropium/Olodaterol Delivered via Soft Mist Inhaler in COPD Patients Stratified by Peak Inspiratory Flow.

Donald A Mahler, Andrea Ludwig-Sengpiel, Gary T Ferguson, Alberto de la Hoz, John Ritz, Asif Shaikh, Henrik Watz

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 25% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Clinical Implications of Peak Inspiratory Flow in COPD: Post Hoc Analyses of the TRONARTO Study.International journal of chronic obstructive pulmonary disease · 2023
    Article
  4. Observational
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

7 authors at 4 institutions in 2 countries.

Donald A MahlerGeisel School of Medicine at Dartmouth, Hanover, NH, USA.ORCID 0000-0001-6332-4895
Andrea Ludwig-SengpielKLB Gesundheitsforschung Lübeck GmbH, Lübeck, Germany.
Gary T FergusonDepartment of Medicine, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Alberto de la HozCardio-Metabolism and Respiratory, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
John RitzBiostatistics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Asif ShaikhClinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.ORCID 0000-0002-5116-9338
Henrik WatzPulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany.
Boehringer Ingelheim (United States) · USBoehringer Ingelheim (Germany) · DEDartmouth College · USGerman Center for Lung Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInhaled bronchodilator therapy is currently the mainstay of treatment for patients with chronic obstructive pulmonary disease (COPD). Some inhalers require patients to achieve certain inhalation efforts either to activate the device or to deliver medication to the site of action. For dry powder inhalers, low peak inspiratory flow (PIF) can result in poor medication delivery but the clinical significance of this is not well understood.

methodsTRONARTO was a 4-week, randomized, double-blind, placebo-controlled, multicenter, parallel-group study which stratified patients with moderate-to-severe COPD according to their PIF against medium-low resistance at screening. Patients were randomized to receive tiotropium/olodaterol (5 μg/5 μg) or matched placebo delivered via the Respimat

resultsOverall, 213 patients were randomized, of whom 106 received tiotropium/olodaterol (PIF <60 L/min, 55; PIF ≥60 L/min, 51) and 107 received placebo (PIF <60 L/min, 55; PIF ≥60 L/min, 52). For FEV

conclusionIn the TRONARTO study, which included patients with moderate-to-severe COPD and varying inspiratory flow abilities, treatment with tiotropium/olodaterol resulted in significant lung function improvements versus placebo. This SMI can be used irrespective of the PIF that a patient can generate.

Indexed as

Pulmonary Disease, Chronic ObstructiveBenzoxazinesBronchodilator AgentsDry Powder InhalersHumansTiotropium BromideBenzoxazinesBronchodilator AgentsolodaterolTiotropium Bromideinhalerlung functionpeak inspiratory flowSMItiotropium/olodaterol

Identifiers

PMID34511891
PMCPMC8414074
OpenAlexW3196494070

What OpenQuestion holds

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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.