Clinical trials for Aironite

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Clinical trials for Aironite

Aironite – Phase 2, HFpEF (“INDIE”)

Aironite has been selected by the Heart Failure Clinical Research Network (HFN) for evaluation in a 100-patient, multicenter, randomized, double-blind, placebo-controlled, Phase 2 clinical trial known as the Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) study.  The HFN is made up of premier clinical centers located across North America and was established to expedite clinical research on treatments and strategies to improve the management of acute and chronic heart failure. The HFN is providing the platform to conduct the INDIE-HFpEF study. Savara will provide test materials, nebulizers, and regulatory, technical, and additional financial support. For more information, please visit the study detail page at ClinicalTrials.gov.

Aironite – Phase 2, HFpEF (“INABLE”)

The study is being conducted by the Mayo Clinic with additional NIH funding. Savara will provide study drug and nebulizers for the study, but no direct financial support.

The Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in HFpEF (“INABLE”) study is an investigator-sponsored, single-center, randomized, double blind, interventional study to evaluate whether Aironite improves clinical responses and tolerability of exercise training (ET) in patients with a diagnosis of HFpEF (n=68).

Patients will undergo 12 weeks of cardiac rehabilitation including ET after being randomized to Aironite or placebo inhalation solution through the training period.  The primary endpoint of this study is change in exercise capacity as measured by peak oxygen consumption. Patient recruitment has been initiated. For more information, please visit the study detail page at ClinicalTrials.gov.

Aironite – Phase 2, Chronic Infection in Cystic Fibrosis

The study is being conducted by the University of Pittsburgh and the University of Pittsburgh Medical Center. Savara will provide study drug and nebulizers for the study, but no direct financial support.

The objective of the open-label Phase 1/2 study is to determine the safety of Aironite, a sterile, proprietary sodium nitrite solution for intermittent inhalation, administered in a dose escalation manner to adults with CF and P. aeruginosa airway infection. The study also aims to explore the effects of Aironite on measures of lung function, exhaled airway nitric oxide, and bacterial density. Under the agreement with the University of Pittsburgh, the Savara has rights to use the data and study results for potential regulatory submissions. Patient recruitment has been initiated. For more information, please visit the study detail page at ClinicalTrials.gov.

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