Crossover Patient Outcomes for Targeted Lung Denervation in Moderate to Severe Chronic Obstructive Pulmonary Disease: AIRFLOW-2.

Bronchoscopy Chronic obstructive pulmonary disease Emphysema Interventional pulmonology Pulmonary medicine

Journal

Respiration; international review of thoracic diseases
ISSN: 1423-0356
Titre abrégé: Respiration
Pays: Switzerland
ID NLM: 0137356

Informations de publication

Date de publication:
2022
Historique:
received: 12 05 2022
accepted: 06 09 2022
pubmed: 28 10 2022
medline: 29 11 2022
entrez: 27 10 2022
Statut: ppublish

Résumé

Targeted Lung Denervation (TLD) is a potential new therapy for COPD. Radiofrequency energy is bronchoscopically delivered to the airways to disrupt pulmonary parasympathetic nerves, to reduce bronchoconstriction, mucus hypersecretion, and bronchial hyperreactivity. This work assesses the effect of TLD on COPD exacerbations (AECOPD) in crossover subjects in the AIRFLOW-2 trial. The AIRFLOW-2 trial is a multicentre, randomized, double-blind, sham-controlled crossover trial of TLD in COPD. Patients with symptomatic COPD on optimal medical therapy with an FEV1 of 30-60% predicted received either TLD or sham bronchoscopy in a 1:1 randomization. Those in the sham arm had the opportunity to cross into the treatment arm after 12 months. The primary end point was rate of respiratory adverse events. Secondary end points included adverse events, changes in lung function and health-related quality of life and symptom scores. Twenty patients were treated with TLD in the crossover phase and were subsequently followed up for 12 months (50% female, mean age 64.1 ± 6.9 years). After TLD, there was a trend towards a reduction in time to first AECOPD (hazard ratio 0.65, p = 0.28, not statistically significant) in comparison to sham follow-up period. There was also a reduction in time to first severe AECOPD in the crossover period (hazard ratio 0.38, p = 0.227, not statistically significant). Symptom scores and lung function showed stability. AIRFLOW-2 crossover data support that of the randomization phase, showing trends towards reduction in COPD exacerbations with TLD.

Sections du résumé

BACKGROUND
Targeted Lung Denervation (TLD) is a potential new therapy for COPD. Radiofrequency energy is bronchoscopically delivered to the airways to disrupt pulmonary parasympathetic nerves, to reduce bronchoconstriction, mucus hypersecretion, and bronchial hyperreactivity.
OBJECTIVES
This work assesses the effect of TLD on COPD exacerbations (AECOPD) in crossover subjects in the AIRFLOW-2 trial.
METHOD
The AIRFLOW-2 trial is a multicentre, randomized, double-blind, sham-controlled crossover trial of TLD in COPD. Patients with symptomatic COPD on optimal medical therapy with an FEV1 of 30-60% predicted received either TLD or sham bronchoscopy in a 1:1 randomization. Those in the sham arm had the opportunity to cross into the treatment arm after 12 months. The primary end point was rate of respiratory adverse events. Secondary end points included adverse events, changes in lung function and health-related quality of life and symptom scores.
RESULTS
Twenty patients were treated with TLD in the crossover phase and were subsequently followed up for 12 months (50% female, mean age 64.1 ± 6.9 years). After TLD, there was a trend towards a reduction in time to first AECOPD (hazard ratio 0.65, p = 0.28, not statistically significant) in comparison to sham follow-up period. There was also a reduction in time to first severe AECOPD in the crossover period (hazard ratio 0.38, p = 0.227, not statistically significant). Symptom scores and lung function showed stability.
CONCLUSIONS
AIRFLOW-2 crossover data support that of the randomization phase, showing trends towards reduction in COPD exacerbations with TLD.

Identifiants

pubmed: 36302345
pii: 000527455
doi: 10.1159/000527455
doi:

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1069-1074

Subventions

Organisme : Medical Research Council
ID : MR/V00171X/1
Pays : United Kingdom

Informations de copyright

© 2022 The Author(s). Published by S. Karger AG, Basel.

Auteurs

Francesca Conway (F)

Royal Brompton Hospital, Chelsea and Westminster Hospital, National Heart and Lung Institute, Imperial College, London, UK.

James Tonkin (J)

Royal Brompton Hospital, Chelsea and Westminster Hospital, National Heart and Lung Institute, Imperial College, London, UK.

Arschang Valipour (A)

Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna, Austria.

Christophe Pison (C)

CHU Grenoble Alpes, Service Hospitalier Universitaire Pneumologie Physiologie, Inserm1055, Université Grenoble Alpes, Grenoble, France.

Christian Schumann (C)

Clinic of Pneumology, Thoracic Oncology, Sleep and Respiratory Critical Care, Kempten and Immenstadt, Allgäu, Germany.

Peter I Bonta (PI)

Department of Respiratory Medicine, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

Romain Kessler (R)

Service de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France.

Wolfgang Gesierich (W)

Asklepios-Fachkliniken, Munich-Gauting, Comprehensive Pneumology Center Munich, Gauting, Germany.

Kaid Darwiche (K)

Department of Pulmonary Medicine, Section of Interventional Pneumology, Ruhrlandklinik - University Hospital Essen, University of Duisburg-Essen, Essen, Germany.

Bernd Lamprecht (B)

Department of Pulmonary Medicine, Kepler Universitatsklinikum GmbH, Linz, Austria.

Dirk Skowasch (D)

Department of Internal Medicine II, Cardiology, Pneumology, University of Bonn, Bonn, Germany.

Philip J Johnson (PJ)

Nuvaira, Inc., Minneapolis, Minnesota, USA.

Dirk-Jan Slebos (DJ)

Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Pallav L Shah (PL)

Royal Brompton Hospital, Chelsea and Westminster Hospital, National Heart and Lung Institute, Imperial College, London, UK.

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