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King CS, Flaherty KR, Glassberg MK, et al. A Phase-2 Exploratory Randomized Controlled Trial of INOpulse in Patients with Fibrotic Interstitial Lung Disease Requiring Oxygen. Ann Am Thorac Soc. 2021;doi: 10.1513/AnnalsATS.202107-864OC.
King, C. S., Flaherty, K. R., Glassberg, M. K., Lancaster, L., Raghu, G., Swigris, J. J., Argula, R. G., Dudenhofer, R. A., Ettinger, N. A., Feldman, J., Johri, S., Fernandes, P., Parsley, E., Shah, P., & Nathan, S. D. (2021). A Phase-2 Exploratory Randomized Controlled Trial of INOpulse in Patients with Fibrotic Interstitial Lung Disease Requiring Oxygen. Annals of the American Thoracic Society, . https://doi.org/10.1513/AnnalsATS.202107-864OC
King, Christopher S, et al. "A Phase-2 Exploratory Randomized Controlled Trial of INOpulse in Patients with Fibrotic Interstitial Lung Disease Requiring Oxygen." Annals of the American Thoracic Society vol. (2021). doi: https://doi.org/10.1513/AnnalsATS.202107-864OC
King CS, Flaherty KR, Glassberg MK, Lancaster L, Raghu G, Swigris JJ, Argula RG, Dudenhofer RA, Ettinger NA, Feldman J, Johri S, Fernandes P, Parsley E, Shah P, Nathan SD. A Phase-2 Exploratory Randomized Controlled Trial of INOpulse in Patients with Fibrotic Interstitial Lung Disease Requiring Oxygen. Ann Am Thorac Soc. 2021 Oct 22; doi: 10.1513/AnnalsATS.202107-864OC. Epub 2021 Oct 22. PMID: 34678128.
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Ann Am Thorac Soc. 2021 Oct 22; doi: 10.1513/AnnalsATS.202107-864OC. Epub 2021 Oct 22.

A Phase-2 Exploratory Randomized Controlled Trial of INOpulse in Patients with Fibrotic Interstitial Lung Disease Requiring Oxygen.

Annals of the American Thoracic Society

Christopher S King, Kevin R Flaherty, Marilyn K Glassberg, Lisa Lancaster, Ganesh Raghu, Jeffrey J Swigris, Rahul G Argula, Rosemarie A Dudenhofer, Neil A Ettinger, Jeremy Feldman, Shilpa Johri, P Fernandes, Ed Parsley, Parag Shah, Steven D Nathan

Affiliations

  1. Inova Fairfax Hospital, 23146, Advanced Lung Disease and Lung Transplant Clinic, Falls Church, Virginia, United States; [email protected].
  2. University of Michigan, Ann Arbor, United States.
  3. University of Arizona Medical Center - University Campus, 22165, Tucson, Arizona, United States.
  4. Vanderbilt University Medical Center, 12328, Nashville, Tennessee, United States.
  5. University of Washington Medical Center, 21617, Division of Pulmonary and Critical Care Medicine, Seattle, Washington, United States.
  6. National Jewish Health, 2930, Medicine, Denver, Colorado, United States.
  7. Medical University of South Carolina, Pulmonary, Critical Care, Allergy & Sleep Medicine, Charleston , South Carolina, United States.
  8. St Lukes Rehabilitation Hospital, 575996, Chesterfield, Missouri, United States.
  9. Arizona Pulmonary Specialists, Pheonix, United States.
  10. Pulmonary Associates of Richmond Inc, 92331, Richmond, Virginia, United States.
  11. Bellerophon Therapeutics, Warren, New Jersey, United States.
  12. bellerophon therapeutics, Warren, New Jersey, United States.
  13. Inova Fairfax Hospital, 23146, Advanced Lung Disease and Transplant Program, Falls Church, Virginia, United States.

PMID: 34678128 DOI: 10.1513/AnnalsATS.202107-864OC

Abstract

RATIONALE: Patients with fibrotic interstitial lung disease often progress to the point of requiring supplemental oxygen. This is invariably accompanied by an impaired quality of life and limitations on activities of daily living.

OBJECTIVE: This study aimed to assess the improvement in physical activity in patients with interstitial lung disease requiring supplemental oxygen treated with pulsed inhaled nitric oxide (iNO) via INOpulse. Additionally, it sought to explore the safety and clinical benefits of INOpulse on multiple patient reported outcomes.

METHODS: Ambulatory fibrotic lung disease patients on supplemental oxygen were randomized in a 2:1 ratio to iNO at 45 µg/kg ideal body weight (IBW)/hr (iNO45) or placebo for four months (3 months post-baseline) of blinded treatment. The study assessed multiple exploratory efficacy endpoints including moderate-to vigorous physical activity (MVPA) as measured by actigraphy and patient reported outcomes using the UCSD Shortness of Breath Questionnaire (UCSD SOBQ) and the St. George's Respiratory Questionnaire (SGRQ).

RESULTS: 44 patients (30 iNO45, 14 placebo) were enrolled. A placebo-corrected clinical benefit of 12.3-minutes per day increase in MVPA was observed in the iNO45 group. Clinically meaningful beneficial trends were observed for the UCSD SOBQ (6.05 points) and the SGRQ Total (3.75) scores, as well as the SGRQ activity (5.84), and SGRQ Impact (6.30) domains.

CONCLUSIONS: INOpulse was well tolerated and associated with maintenance of physical activity and improved symptomatology in patients with interstitial lung disease who require supplemental oxygen. Further validation of this beneficial effect warrants further study in a phase 3 trial that is currently underway. Clinical Trial Registration with ClinicalTrials.gov: NCT03267108 Primary Source of Funding: Bellerophon Therapeutics.

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