Clinical Evidence

Results across our clinical development program demonstrate the safety and impact of Targeted Lung Denervation (TLD) using the dNerva® Lung Denervation System. Detailed information regarding Nuvaira clinical studies can also be found at www.clinicaltrials.gov.

Our AIRFLOW-3 Trial is Enrolling Now!

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dNerva® Clinical Development Program

Phase 1A (Proof of Concept/Dose Ranging)

  • N = 37
  • Single Arm
  • Dose Ranging
  • Proof of Concept
3-Year Data Published25

Phase 2A (Safety/Dose Ranging)

  • N = 46
  • Single Arm
  • Dose Ranging
  • Safety
1-Year Data Published27
3-Year Data Published21

Phase 2B (Safety and Feasibility)

  • N = 82
  • Safety & Feasibility
  • 1:1 Randomized Sham Controlled Double-Blinded (for one year)
  • Crossover
  • EU
1-Year Data Published26
2-Year Data Published2

Phase 3 (Pivotal)

  • N = Up to 400
  • Safety & Feasibility
  • 1:1 Randomized Sham Controlled Double-Blinded (for one year)
  • Crossover
  • USA / EU
Trial enrolling patients

Studies

Find out more about each of the studies in Nuvaira’s clinical development program.

Clinical Development Program AIRFLOW-2

Study Overview

AIRFLOW-2 was a double-blinded, sham controlled, multicenter randomized clinical trial to assess respiratory adverse events in 82 moderate-to-severe COPD patients with high symptom burden despite optimal drug therapy. Results from our AIRFLOW-2 Clinical Trial confirm the safety of the procedure and provides a solid clinical and economic basis for a pivotal trial, AIRFLOW-3.

Results: Impact on Two-Year Outcomes2
62% Lower Risk of Severe Exacerbations
in COPD Patients with TLD

Published in the International Journal of Chronic Obstructive Pulmonary Disease, November 20202

The clinical impact of TLD is durable, as it is found to reduce the risk of serious COPD adverse events over 2 years with stabilized lung function. The reduction of severe COPD exacerbations has the potential to improve long-term clinical outcomes and reduce healthcare costs.

Read the Full Report

AIRFLOW-2 Conclusions

Robust study design

Positive Safety Profile

TLD demonstrated a significantly lower risk of hospitalized COPD exacerbations

Lung function and quality of life remained stable over 2 years

AIRFLOW-2 Study Details

Trial Design / Phase

Evaluate the safety and impact of TLD in moderate-to-severe, symptomatic COPD patients on optimal medical therapy

Patient population

Diagnosed, moderate-to-severe, symptomatic COPD patients at risk of COPD exacerbation (GOLD 2/3, Group D)

Principal investigator(s)

Arschang Valipour, MD, Otto-Wagner Spital (Vienna, Austria)
Dirk-Jan Slebos, MD, Ph.D., UMCG (Groningen, Netherlands)

Primary Endpoint

Difference in rates (percentage) of pre-defined respiratory adverse events between 3 and 6.5 months post-treatment, between TLD and Sham control groups

Sites / Patients

N = 82 (1:1 randomization)
Multicenter EU

Follow-up

0 – 12.5 months (to unblinding), follow-up annually to 2 years

Nuvaira Clinical Development Program AIRFLOW-1

Study Overview

AIRFLOW-1 was a multicenter safety and dose ranging study of TLD in moderate-to-severe COPD patients. Results from our AIRFLOW-1 Clinical Trial show that patient lung function remained stable up to 3 years after treatment and that the annual rate of decline in FEV1 decreased after treatment.21,22

Published in Respiratory Research, February 202121

TLD in COPD patients demonstrated a positive safety profile out to 3 years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over 3 years of follow up.

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Results: Observed Clinical Stability after Three Years21,22

Stable Quality of Life

Stable COPD Exacerbation Rates

Stable Lung Function

AIRFLOW-1 Study Details

Trial Design / Phase

International multicenter safety and dose-ranging study with a randomized (N=30) and confirmatory (N=16) phase

Patient population

Diagnosed, moderate-to-severe, symptomatic COPD patients

Principal investigator(s)

Arschang Valipour, MD, Otto-Wagner Spital (Vienna, Austria)
Dirk-Jan Slebos, MD, Ph.D., UMCG (Groningen, Netherlands)

Primary Endpoint

Rate of airway effects requiring intervention through 3 months (randomized), and rate and frequency of adverse events at one month compared to 32W dose group (confirmatory)

Sites / Patients

N=46
10 sites (Europe)

Follow-up

Three years

Nuvaira Clinical Development Program - AIRFLOW-3

Study Overview

NOW ENROLLING: the first major interventional trial targeting reduction of exacerbations in COPD patients with high symptom burden.

1:1 Randomized, Double-Blind, Sham-Controlled FDA Pivotal Trial

Primary Endpoint:

Comparison of the probability of subjects having a moderate or severe exacerbation between the treatment arm and the sham control arm at one year

Up to 400 participants

Multicenter (USA, Europe)

Find a Participating Clinic

AIRFLOW-3 Study Details

Trial Design / Phase

International Multicenter, Randomized, Double-blinded, Sham-Controlled, Superiority
Phase III Pivotal trial

Patient population

Diagnosed, moderate-to-severe, symptomatic COPD patients at risk of COPD exacerbation (GOLD 2/3, Group D)

Principal investigator(s)

Frank Sciurba, MD, UPMC (Pittsburgh PA USA)
Dirk-Jan Slebos, MD, Ph.D., UMCG (Groningen Netherlands)

Primary Endpoint

Comparison of rate of moderate or severe COPD exacerbations (time-to-first-event analysis) between TLD+Medical Management vs. Sham+Medical Management, 0-12 months

Sites / Patients

N = Up to 400 (1:1 randomization)
40 total sites: USA (25), OUS (15)

Follow-up

Primary Endpoint: one year
Unblinding and opportunity to cross over for patients in sham arm: one year
Annual follow-up to 5 years

Publications

Targeted Lung Denervation Bibliography

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Targeted Lung Denervation Mechanism of Action Bibliography

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COPD Exacerbations are the Problem.
Be a Part of the Solution.

The AIRFLOW-3 Clinical Trial is the first interventional COPD trial targeting exacerbation risk reduction in patients on optimal drug therapy.

See if Your Patient May Be a Candidate