Evidence map›Paper›PMID 33177818›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2020

Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2.

Arschang Valipour, Pallav L Shah, Felix J Herth, Christophe Pison, Christian Schumann, Ralf-Harto Hübner, Peter I Bonta, Romain Kessler, Wolfgang Gesierich, Kaid Darwiche and 14 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02058459 (A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.3field-weighted citation impact, top 9% 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.

NCT02058459 nacompletednot on this map

A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.

TypeinterventionalSponsorNuvaira, Inc.Ran2014 to 2020Enrolled128ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsHolaira™ Lung Denervation System with energy delivery, Holaira™ Lung Denervation System without energy delivery
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
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  14. Airway Innervation and Plasticity in Asthma.Physiology (Bethesda, Md.) · 2019
    Review
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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

24 authors at 19 institutions in 6 countries.

Arschang ValipourDepartment of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria.
Pallav L ShahRoyal Brompton & Harefield NHS Trust, Chelsea & Westminster Hospital and Imperial College, London, UK.ORCID 0000-0002-9052-4638
Felix J HerthThoraxklinik, Department of Pneumology and Critical Care Medicine and Translational Lung Research Center Heidelberg (TLRCH), University of Heidelberg, Heidelberg, Germany.ORCID 0000-0002-7638-2506
Christophe PisonCHU Grenoble Alpes, Service Hospitalier Universitaire Pneumologie Physiologie; Université Grenoble Alpes, Grenoble, France.
Christian SchumannClinic of Pneumology, Thoracic Oncology, Sleep- and Respiratory Critical Care, Klinikverbund Allgaeu, Kempten and Immenstadt, Germany.ORCID 0000-0001-8143-5978
Ralf-Harto HübnerCharité Universitätsmedizin Berlin, Medizinische Klinik m. Schw. Infektiologie und Pneumologie, Campus Virchow, Berlin, Germany.
Peter I BontaDepartment of Respiratory Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-0429-4988
Romain KesslerService de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France.ORCID 0000-0002-5798-5715
Wolfgang GesierichAsklepios-Fachkliniken Munich-Gauting, Comprehensive Pneumology Center Munich, Gauting, Germany.ORCID 0000-0001-6707-6358
Kaid DarwicheDepartment of Pulmonary Medicine, Section of Interventional Pneumology, Ruhrlandklinik - University Hospital Essen, University of Duisburg-Essen, Essen, Germany.ORCID 0000-0003-0681-1325
Bernd LamprechtDepartment of Pulmonary Medicine, Kepler Universitatsklinikum GmbH, Linz, Austria.
Thierry PerezCHU de Lille - Hôpital Calmette, Lille, France.ORCID 0000-0003-2749-0903
Dirk SkowaschDepartment of Internal Medicine II - Cardiology/Pneumology, University of Bonn, Bonn, Germany.
Gaetan DesleeCHU de Reims, Hôpital Maison Blanche, Service de Pneumologie, Reims, France.
Armelle MarceauService de Pneumologie, Hôpital Universitaire Bichat, Paris, France.
Frank C SciurbaUniversity of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Reinoud GosensDepartment of Molecular Pharmacology, University of Groningen, Groningen, the Netherlands.
Jorine E HartmanDepartment of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.ORCID 0000-0001-8765-9673
Francesca ConwayRoyal Brompton & Harefield NHS Trust, Chelsea & Westminster Hospital and Imperial College, London, UK.ORCID 0000-0002-7965-5485
Marina DullerDepartment of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria.
Martin MayseNuvaira, Inc., Minneapolis, MN, USA.
Holly S NormanNuvaira, Inc., Minneapolis, MN, USA.
Dirk-Jan SlebosDepartment of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.ORCID 0000-0001-9555-3422
AIRFLOW-2 Trial Study Group
Chelsea and Westminster Hospital · GBKarl Landsteiner Society · ATNuvaira (United States) · USUniversity Medical Center Groningen · NLAmsterdam UMC Location University of Amsterdam · NLAsklepios Fachkliniken München-Gauting · DECentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Lille · FRCentre Hospitalier Universitaire de Reims · FRCharité - Universitätsmedizin Berlin · DEHeidelberg University · DEHôpital Bichat-Claude-Bernard · FRHôpital Civil, Strasbourg · FRKepler Universitätsklinikum · ATKlinikverbund Südwest · DERuhrlandklinik · DEUniversity of Bonn · DEUniversity of Groningen · NLUniversity of Pittsburgh · US

Funding

Medical Research Council MR/V00171X/1
6 · The paper itself

Abstract

Purpose: COPD exacerbations are associated with worsening clinical outcomes and increased healthcare costs, despite use of optimal medical therapy. A novel bronchoscopic therapy, targeted lung denervation (TLD), which disrupts parasympathetic pulmonary innervation of the lung, has been developed to reduce clinical consequences of cholinergic hyperactivity and its impact on COPD exacerbations. The AIRFLOW-2 study assessed the durability of safety and efficacy of TLD additive to optimal drug therapy compared to sham bronchoscopy and optimal drug therapy alone in subjects with moderate-to-severe, symptomatic COPD two years post randomization. Patients and Methods: TLD was performed in COPD patients (FEV Results: Eighty-two subjects (FEV Conclusion: In a randomized trial, TLD demonstrated a durable effect of significantly lower risk of severe AECOPD over 2 years. Further, lung function and quality of life remained stable following TLD. Clinical Trial Registration: NCT02058459.

Indexed as

Pulmonary Disease, Chronic ObstructiveDenervationDouble-Blind MethodFemaleForced Expiratory VolumeHumansLungMaleQuality of LifebronchoscopyCOPDCOPD exacerbationtargeted lung denervation

Identifiers

PMID33177818
PMCPMC7652218
OpenAlexW3095201741

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.