Clinical Studies

Nuvaira is committed to conducting rigorous clinical studies in our quest to develop disease-altering therapies for patients with obstructive lung diseases. Detailed information regarding all Nuvaira clinical studies can be found at www.clinicaltrials.gov.

Nuvaira’s COPD Clinical Development Program

Current Clinical Studies:

AIRFLOW-3 NCT03639051

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 = 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

View Airflow 3 Trial Website

AIRFLOW-2 NCT02058459

Trial Design / Phase	International multicenter randomized, double-blinded, sham-controlled study
Patient Population	Diagnosed, moderate-to-severe, symptomatic COPD patients
Principal Investigator(s)	Dirk-Jan Slebos, MD, Ph.D., UMCG (Groningen, Netherlands) Arschang Valipour, MD, Otto-Wagner Spital (Vienna, Austria)
Primary Endpoint	Rate of respiratory adverse events between 3 and 6.5 months post-randomization
Sites / Patients	N=82 (1:1 randomization) 16 total sites (Europe)
Follow-up	Primary endpoint: 6.5 months Unblinding and opportunity to cross-over for patients in sham arm: one year Annual follow-up to 5 years

AIRFLOW-1 NCT02058459

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