Evidence map›Paper›PMID 25739911›Full record

Trial reportThorax2015

Targeted lung denervation for moderate to severe COPD: a pilot study.

Dirk-Jan Slebos, Karin Klooster, Coenraad F N Koegelenberg, Johan Theron, Dorothy Styen, Arschang Valipour, Martin Mayse, Chris T Bolliger

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Thorax, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01483534 (Evaluation of the Innovative Pulmonary Solutions), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
8.6field-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.

NCT01483534 phase1completednot on this map

Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study

TypeinterventionalSponsorNuvaira, Inc.Ran2011 to 2015Enrolled22ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsTLD Therapy (IPS SystemTM)
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 96 citations in OpenAlex.

  1. Trial
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  7. Interventional pulmonology for chronic inflammatory airway diseases.Chinese medical journal pulmonary and critical care medicine · 2024
    Review
  8. ERJ Advances: interventional bronchoscopy.The European respiratory journal · 2024
    Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Article
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  16. Current status of interventional therapy for pulmonary emphysema with bronchoscopy.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2022
    Review
  17. Bronchoscopic Targeted Lung Denervation in Patients with Severe Asthma: Preliminary Findings.Respiration; international review of thoracic diseases · 2022
    Article
  18. Article
  19. Review
  20. New bronchoscopic treatment modalities for patients with chronic bronchitis.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
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

8 authors at 7 institutions in 4 countries.

Dirk-Jan SlebosDepartment of Pulmonary diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Karin KloosterDepartment of Pulmonary diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Coenraad F N KoegelenbergFaculty of Medicine and Health Sciences, Division of Pulmonology, Department of Medicine, Stellenbosch University, Cape Town, South Africa.
Johan TheronMedi Clinic Panorama, Cape Town, South Africa.
Dorothy StyenFaculty of Medicine and Health Sciences, Division of Pulmonology, Department of Medicine, Stellenbosch University, Cape Town, South Africa.
Arschang ValipourDepartment of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Vienna, Austria.
Martin MayseHolaira, Inc., Minneapolis, Minnesota, USA.
Chris T BolligerFaculty of Medicine and Health Sciences, Division of Pulmonology, Department of Medicine, Stellenbosch University, Cape Town, South Africa Medi Clinic Panorama, Cape Town, South Africa.
Altair Engineering (United States) · USLudwig Boltzmann Institute for COPD And Respiratory Epidemiology · ATPanorama Research (United States) · USStellenbosch University · ZAUniversity Medical Center Groningen · NLUniversity of Groningen · NLWestern Cape Department of Health · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundParasympathetic pulmonary nerves release acetylcholine that induces smooth muscle constriction. Disruption of parasympathetic pulmonary nerves improves lung function and COPD symptoms.

aimsTo evaluate 'targeted lung denervation' (TLD), a novel bronchoscopic therapy based on ablation of parasympathetic pulmonary nerves surrounding the main bronchi, as a potential therapy for COPD.

methodsThis 1-year, prospective, multicentre study evaluated TLD in patients with COPD forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) (FEV1/FVC <0.70; FEV1 30%-60% predicted). Patients underwent staged TLD at 20 watts (W) or 15 W following baseline assessment off bronchodilators. Assessments were repeated on tiotropium before treatment and off bronchodilators at 30, 90, 180, 270 and 365 days after TLD. The primary endpoint was freedom from documented and sustained worsening of COPD directly attributable to TLD to 1 year. Secondary endpoints included technical feasibility, change in pulmonary function, exercise capacity, and quality of life.

resultsTwenty-two patients were included (n=12 at 20 W, n=10 at 15 W). The procedures were technically feasible 93% of the time. Primary safety endpoint was achieved in 95%. Asymptomatic bronchial wall effects were observed in 3 patients at 20 W. The clinical safety profiles were similar between the two energy doses. At 1 year, changes from baseline in the 20 W dose compared to the 15 W dose were: FEV1 (+11.6%±32.3 vs +0.02%±15.1, p=0.324), submaximal cycle endurance (+6.8 min±12.8 vs 2.6 min±8.7, p=0.277), and St George's Respiratory Questionnaire (-11.1 points ±9.1 vs -0.9 points ±8.6, p=0.044).

conclusionsBronchoscopic TLD, based on the concept of ablating parasympathetic pulmonary nerves, was feasible, safe, and well tolerated. Further investigation of this novel therapy is warranted. TRIAL REGISTRATION NUMBER: NCT01483534.

Indexed as

BronchoscopyAgedCatheter AblationCohort StudiesExercise ToleranceFeasibility StudiesFemaleForced Expiratory VolumeHumansMaleMiddle AgedParasympathectomyPilot ProjectsPulmonary Disease, Chronic ObstructiveQuality of LifeTotal Lung CapacityBronchoscopyCOPD ÀÜ Mechanisms

Identifiers

PMID25739911
PMCPMC4413833
OpenAlexW2112048787

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.