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 |
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 |