Evidence map›Paper›PMID 31220851›Full record

Trial reportRespiration; international review of thoracic diseases

Safety and Dose Study of Targeted Lung Denervation in Moderate/Severe COPD Patients.

Arschang Valipour, Pallav L Shah, Christophe Pison, Vincent Ninane, Wim Janssens, Thierry Perez, Romain Kessler, Gaetan Deslee, Justin Garner, Christine Abele and 3 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiration; international review of thoracic diseases. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
4.4field-weighted citation impact, top 5% 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

17 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Interventional pulmonology for chronic inflammatory airway diseases.Chinese medical journal pulmonary and critical care medicine · 2024
    Review
  8. Review
  9. Review
  10. Article
  11. Bronchoscopic Targeted Lung Denervation in Patients with Severe Asthma: Preliminary Findings.Respiration; international review of thoracic diseases · 2022
    Article
  12. New bronchoscopic treatment modalities for patients with chronic bronchitis.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  13. Bronchoscopic management of asthma, COPD and emphysema.European respiratory review : an official journal of the European Respiratory Society · 2021
    Article
  14. Review
  15. Article
  16. Article
  17. 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

13 authors at 8 institutions in 5 countries.

Arschang ValipourDepartment of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Vienna, Austria.
Pallav L ShahRoyal Brompton and Harefield NHS Trust, Chelsea and Westminster Hospital, and Imperial College, London, United Kingdom.
Christophe PisonService Hospitalier Universitaire Pneumologie Physiologie, Centre Hospitalier Universitaire Grenoble Alpes, InsermU1055, Université Grenoble Alpes, Grenoble, France.
Vincent NinaneCHU Saint-Pierre, Université libre de Bruxelles, Bruxelles, Belgium.
Wim JanssensDepartment of Respiratory Diseases, KU Leuven, University Hospitals Leuven, Leuven, Belgium.
Thierry PerezCHU Lille, Center for Infection and Immunity of Lille, INSERM U1019, CNRS UMR 8204 Univ Lille Nord de France, Lille, France.
Romain KesslerService de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France.
Gaetan DesleeCHU de Reims, Hôpital Maison Blanche, INSERM UMRS 1250, Service de Pneumologie, Reims, France.
Justin GarnerRoyal Brompton and Harefield NHS Trust, Chelsea and Westminster Hospital, and Imperial College, London, United Kingdom.
Christine AbeleDepartment of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Vienna, Austria.
Jorine E HartmanDepartment of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Dirk-Jan SlebosDepartment of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands, d.j.slebos@umcg.nl.
On behalf of the AIRFLOW-1 Study Group
Chelsea and Westminster Hospital NHS Foundation Trust · GBInserm · FRLudwig Boltzmann Institute for Lung Health · ATUniversity Medical Center Groningen · NLCentre National de la Recherche Scientifique · FRHôpital Civil, Strasbourg · FRKU Leuven · BEUniversité Libre de Bruxelles · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleTargeted lung denervation (TLD) is a novel bronchoscopic treatment for the disruption of parasympathetic innervation of the lungs.

objectivesTo assess safety, feasibility, and dosing of TLD in patients with moderate to severe COPD using a novel device design.

methodsThirty patients with COPD (forced expiratory volume in 1 s 30-60%) were 1:1 randomized in a double-blinded fashion to receive TLD with either 29 or 32 W. Primary endpoint was the rate of TLD-associated adverse airway effects that required treatment through 3 months. Assessments of lung function, quality of life, dyspnea, and exercise capacity were performed at baseline and 1-year follow-up. An additional 16 patients were enrolled in an open-label confirmation phase study to confirm safety improvements after procedural enhancements following gastrointestinal adverse events during the randomized part of the trial.

resultsProcedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group, p = 0.6. Five patients early in the randomized phase experienced serious gastric events. The study was stopped and procedural changes made that reduced both gastrointestinal and airway events in the subsequent phase of the randomized trial and follow-up confirmation study. Improvements in lung function and quality of life were observed compared to baseline values for both doses but were not statistically different.

conclusionsThe results demonstrate acceptable safety and feasibility of TLD in patients with COPD, with improvements in adverse event rates after procedural enhancements.

Indexed as

AgedBronchoscopyFemaleHumansLungMaleMiddle AgedParasympathectomyPulmonary Disease, Chronic ObstructiveAcetylcholineBronchoscopyLung disease obstructiveParasympathectomyRadiofrequency ablation

Identifiers

PMID31220851
PMCPMC6878750
OpenAlexW2949920311

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.