Evidence map›Paper›PMID 32054473›Full record

ArticleBMC pulmonary medicine2020

Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3).

Dirk-Jan Slebos, Bruno Degano, Arschang Valipour, Pallav L Shah, Gaetan Deslée, Frank C Sciurba, AIRFLOW-3 Trial Study Group

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pulmonary medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03639051 (A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Patients with Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.7field-weighted citation impact, top 8% 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.

NCT03639051 naactive not recruitingnot on this map

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Patients with Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorNuvaira, Inc.Ran2019 to 2028Enrolled464ConditionsCOPDArmsTargeted Lung Denervation (TLD), Optimal Medical Care
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Interventional pulmonology for chronic inflammatory airway diseases.Chinese medical journal pulmonary and critical care medicine · 2024
    Review
  6. ERJ Advances: interventional bronchoscopy.The European respiratory journal · 2024
    Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Bronchoscopic management of asthma, COPD and emphysema.European respiratory review : an official journal of the European Respiratory Society · 2021
    Article
  12. 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

7 authors at 5 institutions in 5 countries.

Dirk-Jan SlebosDepartment of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713RB, Groningen, The Netherlands. d.j.slebos@umcg.nl.
Bruno DeganoDepartment of Respiratory Medicine, CHU de Grenoble Alpes, Grenoble, France.
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.
Gaetan DesléeCHU de REIMS, Hôpital Maison Blanche Service des Maladies Respiratoires INSERM 1250, 45 rue Cognacq Jay, 51092, Reims Cedex, France.
Frank C SciurbaUniversity of Pittsburgh School of Medical Center, 200 Lothrop Street, Pittsburgh, PA, 15213, USA.
AIRFLOW-3 Trial Study Group
Inserm · FRUniversity Medical Center Groningen · NLCentre Hospitalier Universitaire de Grenoble · FRChelsea and Westminster Hospital · GBUniversity of Pittsburgh Medical Center · US

Funding

Nuvaira Sponsor
6 · The paper itself

Abstract

backgroundTargeted lung denervation (TLD) is a bronchoscopically delivered ablation therapy that selectively interrupts pulmonary parasympathetic nerve signaling. The procedure has the potential to alter airway smooth muscle tone and reactivity, decrease mucous secretion, and reduce airway inflammation and reflex airway hyperresponsiveness. Secondary outcome analysis of a previous randomized, sham-controlled trial showed a reduction in moderate-to-severe exacerbations in patients with COPD after TLD treatment. A pivotal trial, AIRFLOW-3 has been designed to evaluate the safety and efficacy of TLD combined with optimal medical therapy to reduce moderate or severe exacerbations throughout 1 year, compared with optimal medical therapy alone.

methodsThe study design is a multicenter, randomized, full sham bronchoscopy controlled, double-blind trial that will enroll 400 patients (1:1 randomization). Key inclusion criteria are FEV DISCUSSION: The multicenter, randomized, full sham bronchoscopy controlled, double-blind AIRFLOW-3 trial will evaluate the efficacy of TLD to reduce moderate or severe COPD exacerbations beyond optimal medical therapy alone. The target population are patients with COPD, who suffer persistent symptoms and exacerbations despite optimal treatment, defining an unmet medical need requiring novel therapeutic solutions. This trial is registered at clinicaltrials.gov: NCT03639051.

Indexed as

BronchoscopyRadiofrequency AblationBronchodilator AgentsDenervationDisease ProgressionDouble-Blind MethodForced Expiratory VolumeHumansMulticenter Studies as TopicProspective StudiesPulmonary Disease, Chronic ObstructiveRandomized Controlled Trials as TopicTreatment OutcomeBronchodilator AgentsAcetylcholineAnticholinergicBronchoscopyCOPDNervesTargeted lung denervation

Identifiers

PMID32054473
PMCPMC7020591
OpenAlexW3006628521

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.