Methods of using inhaled nitric oxide gas for treatment of acute respiratory distress syndrome in children
Inventors
Potenziano, Jim • Bronicki, Ronald • Baldassarre, James
Assignees
Mallinckrodt IP • Mallinckrodt Pharma IP Trading DAC • Mallinckrodt Pharmaceuticals Ireland Ltd • Therakos Inc • INO Therapeutics LLC
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Publication Number
US-10201564-B2
Publication Date
2019-02-12
Expiration Date
Abstract
The present invention provides a treatment of acute respiratory distress syndrome (ARDS) in children using dosing of nitric oxide at low concentrations, such as less than 10 ppm.
Core Innovation
The invention is directed to methods of treating acute respiratory distress syndrome (ARDS) in children by administering a gas comprising nitric oxide (NO). The administration is characterized by a NO dose and a treatment period, and is intended to increase the number of days that the child is alive and ventilator-free at 28 days after the start of NO administration. The disclosed approach is based on low-dose inhaled nitric oxide (iNO) in the range from about 2 ppm to about 8 ppm NO, including about 2 ppm to about 6 ppm NO and about 5 ppm NO in representative studies.
The disclosed method specifies pediatric use conditions, including children in need thereof and age constraints in at least one formulation that is directed to children less than 17 years old. The treatment period is at least 24 hours in one independent method and at least 2 days in another independent method, and the administration is associated with improvements in days alive and ventilator-free at 28 days after the start of NO administration. The administration is also described as ECMO-free within the claimed treatment setting.
The invention further includes eligibility and assessment criteria used to define the pediatric ARDS population, including oxygenation index thresholds and PaO2/FiO2 ratio criteria, and diagnostic imaging criteria involving chest X-ray findings. The disclosed criteria include oxygenation index of greater than or equal to 12 cm H2O/mmHg and a PaO2/FiO2 ratio of less than 300 in certain embodiments. Chest X-ray criteria include unilateral infiltrates taken within 24 hours of starting treatment.
Claims Coverage
The disclosed claim set includes three independent claims directed to methods of treating acute respiratory distress syndrome (ARDS) in children. Across the independent claims, the core inventive features include pediatric NO gas dosing at specified ppm ranges, a specified treatment duration, an outcome tied to increased days alive and ventilator-free at 28 days, and ECMO-free administration, with further eligibility refinements based on oxygenation and imaging criteria.
Low-dose nitric oxide treatment to increase days alive and ventilator-free at 28 days
A method of treating acute respiratory distress syndrome (ARDS) in children comprising administering a gas comprising nitric oxide (NO) to a child in need thereof at a dose in the range from about 2 ppm to about 8 ppm NO for a treatment period of at least 24 hours, wherein administration of NO increases the number of days that the child is alive and ventilator-free at 28 days after the start of NO administration.
Low-dose nitric oxide treatment for at least 2 days to increase days alive and ventilator-free at 28 days
A method of treating acute respiratory distress syndrome (ARDS) in children comprising administering a gas comprising nitric oxide (NO) to a child in need thereof at a dose in the range from about 2 ppm to about 6 ppm NO for a treatment period of at least 2 days, wherein administration of NO increases the number of days that the child is alive and ventilator-free at 28 days after the start of NO administration.
Specific pediatric age <17 low-dose nitric oxide to increase days alive and ventilator-free at 28 days
A method of treating acute respiratory distress syndrome (ARDS) in children less than 17 years old, the method comprising administering a gas comprising nitric oxide (NO) to a child in need thereof at a dose of about 5 ppm NO for a treatment period of at least 24 hours, wherein administration of NO increases the number of days that the child is alive and ventilator-free at 28 days after the start of NO administration.
Across the independent claims, the coverage is directed to treating pediatric ARDS using a gas comprising nitric oxide at specified low-dose ppm ranges for at least 24 hours or at least 2 days, with the stated functional outcome of increasing the number of days the child is alive and ventilator-free at 28 days after initiating NO. The claim excerpts also include ECMO-free administration conditions and patient eligibility parameters based on oxygenation and imaging criteria.
Stated Advantages
Increases the number of days that the child is alive and ventilator-free at 28 days after the start of NO administration.
Improved oxygenation index over early timepoints.
Increased ECMO-free survival.
Documented Applications
Treating acute respiratory distress syndrome (ARDS) in children using low-dose inhaled nitric oxide (iNO) as an ECMO-free administration approach.
Treating pediatric ARDS population defined by oxygenation and chest X-ray criteria, in particular including children less than 17 years old treated with about 5 ppm NO for at least 24 hours.
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