Targeted lung denervation may be a potential new therapy for COPD authors of a first-in-human study say, but an expert says that while the study is interesting it’s too early to get excited by the results.
In patients with COPD parasympathetic pulmonary nerves release acetycholine causing smooth muscle contraction and increased mucus production which contributes to airway obstruction.
Writing in Thorax, the researchers from The Netherlands and South Africa say a new bronchoscopic therapy they are trialling called ‘targeted lung denervation’ ablates these nerves and is a potential treatment option for patients with moderate to severe disease.
In the small safety study 22 patients with moderate to severe COPD underwent rigid brochoscopy to ablate the parasympathetic nerves running along the main bronchi at 20 or 15 watts following a baseline assessment off bronchodilators.
The primary endpoint of freedom from documented and sustained worsening of COPD directly attributable to targeted lung denervation was met by 95% of the patients, the authors reported.
At one 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).
Commenting on the paper Professor Christine McDonald head of Respiratory and Sleep Medicine at Austin Health in Victoria said it was a potentially interesting surgical way of managing cholinergic tone in COPD patients but it was too early to get excited by the results.
To show efficacy the researchers would need to conduct a sham study, she told the limbic.
“A control group would need to have a rigid bronchoscopy and everything but the targeted denervation to really see whether it does have a benefit or not,” she said.
Claims by the authors that the procedure might be a useful way of managing patients who have poor inhaler compliance could just be down to patient selection, McDonald said.
They may have been poor compliers anyway because they weren’t getting a lot of benefit.
There’s a need to look carefully at the selection criteria in the study, she says.
“As with all studies you have to be aware that there are a whole range of exclusion criteria and then it gets rolled out to the whole community.”
“The study is interesting, worth noting, but we’ll watch with interest,” she says.
Conflict of interest note: The study was funded by Holaira Inc and one of the authors was founder and chief technology officer of the study sponsor.