Published Evidence

Three randomised controlled trials document the clinical benefits with an acceptable safety profile

 

Published clinical data is available concerning the treatment of severe emphysema with PneumRx® Endobronchial Coils. Three randomised controlled trials (RCTs) with up to 12 months follow-up and a total of more than 450 patients document a positive effect and acceptable safety profile.1-3 In these three RCTs (RESET1, REVOLENS3 and RENEW2) quality of life, lung function and exercise capacity were improved to a statistically significant degree by BLVR with Coils. In all three trials, the primary endpoint was met and improvement was noted in all other recorded parameters.

The patients’ quality of life score improved by more than twice the Minimal Clinically Important Difference (MCID) in all three trials4. In the opinion of experts, positive changes in the St. George's Respiratory Questionnaire (SGRQ) score reflect the decrease in breathlessness in daily life. The FEV1 values increased after BLVR with Coils in comparison to control patients, while lung RV decreased.

In addition to the RCTs, PneumRx has conducted several open label studies and supported post-hoc analyses of the published data.
 

1Shah PL et al. Lancet Respir Med 2013;1:233-240.
2Sciurba FC et al. JAMA 2016;315:2178-2189.
3Deslee G et al. JAMA 2016;315:175-184.
4Jones PW et al. Eur Respir J 2002;19:398-404

 


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