Methods of administering inhaled nitric oxide gas

Patent metadata

Field	Value
Publication number	US-11931377-B2
Application number	US-201916378361-A
Country	US
Kind code	B2
Filing date	Apr 8, 2019
Priority date	Jun 30, 2009
Publication date	Mar 19, 2024
Grant date	Mar 19, 2024

Abstract

The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.

First claim

I claim:

1. A method for treating a pediatric patient who is experiencing idiopathic pulmonary arterial hypertension resulting in oxygen desaturation, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising:
determining whether the patient has pre-existing left ventricular dysfunction, and
(a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation in the patient, and
(b) if the patient does have pre-existing left ventricular dysfunction, administering inhaled supplemental oxygen to the patient and excluding the patient from treatment with inhaled nitric oxide.

2. A method for treating a pediatric patient who is experiencing oxygen desaturation associated with idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising:
determining whether the patient has pre-existing left ventricular dysfunction, and
(a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide and supplemental oxygen for a length of time sufficient to increase the partial pressure of arterial oxygen (PaO 2 ) in the patient by dilating pulmonary vessels, and
(b) if the patient does have pre-existing left ventricular dysfunction, administering inhaled supplemental oxygen to the patient and excluding the patient from treatment with inhaled nitric oxide.

3. A method for treating a pediatric patient who is experiencing oxygen desaturation associated with idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising:
evaluating the patient, or having the patient evaluated, to determine if the patient has pre-existing left ventricular dysfunction, and
(a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide for a length of time sufficient to improve oxygenation in the patient, and
(b) if the patient does have pre-existing left ventricular dysfunction, administering inhaled supplemental oxygen to the patient and excluding the patient from treatment with inhaled nitric oxide.

4. A method for treating a pediatric patient who is experiencing oxygen desaturation associated with idiopathic pulmonary arterial hypertension, wherein the patient is not dependent on right-to-left shunting of blood, the method comprising:
administering supplemental oxygen to the patient;
determining whether the patient has pre-existing left ventricular dysfunction; and
(a) if the patient does not have pre-existing left ventricular dysfunction, administering to the patient 20 ppm inhaled nitric oxide and supplemental oxygen for a length of time sufficient to increase PaO 2 in the patient by dilating pulmonary vessels, and
(b) if the patient does have pre-existing left ventricular dysfunction, continuing to administer inhaled supplemental oxygen to the patient, and excluding the patient from treatment with inhaled nitric oxide.

5. The method of claim 1 , wherein the risk that inhaled nitric oxide administration will result in pulmonary edema in a pediatric subject is higher if the subject has pre-existing left ventricular dysfunction than if the subject does not have pre-existing left ventricular dysfunction.

6. The method of claim 2 , wherein the risk that inhaled nitric oxide administration will result in pulmonary edema in a pediatric subject is higher if the subject has pre-existing left ventricular dysfunction than if the subject does not have pre-existing left ventricular dysfunction.

7. The method of claim 3 , wherein the risk that inhaled nitric oxide administration will result in pulmonary edema in a pediatric subject is higher if the subject has pre-existing left ventricular dysfunction than if the subject does not have pre-existing left ventricular dysfunction.

8. The method of claim 4 , wherein the risk that inhaled nitric oxide administration will result in pulmonary edema in a pediatric subject is higher if the subject has pre-existing left ventricular dysfunction than if the subject does not have pre-existing left ventricular dysfunction.

9. The method of claim 1 , wherein the determining step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary capillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left vermicular dysfunction.

10. The method of claim 2 , wherein the determining step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary capillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left ventricular dysfunction.

11. The method of claim 3 , wherein the evaluating step comprises measuring, or having measured, the patient's pulmonary capillary wedge pressure, and concluding that, if the pulmonary capillary wedge pressure is greater than 20 mmHg, the patient has pre-existing left ventricular dysfunction.

12. The method of claim 1 , wherein the determining step comprises (i) assessing, or having assessed, the patient's clinical signs and symptoms of heart failure; or (ii) using, or having used, echocardiography diagnostic screening.

13. The method of claim 2 , wherein the determining step comprises (i) assessing, or having assessed, the patient's clinical signs and symptoms of heart failure; or (ii) using, or having used, echocardiography diagnostic screening.

14. The method of claim 3 , wherein the evaluation step comprises (i) assessing, or having assessed, the patient's clinical signs and symptoms of heart failure; or (ii) using, or having used, echocardiography diagnostic screening.

15. The method of claim 1 , wherein the pre-existing left ventricular dysfunction of (b) is attributable to congenital heart disease.

16. The method of claim 2 , wherein the pre-existing left ventricular dysfunction of (b) is attributable to congenital heart disease.

17. The method of claim 3 , wherein the pre-existing left ventricular dysfunction of (b) is attributable to congenital heart disease.

18. The method of claim 1 , wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction.

19. The method of claim 2 , wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction.

20. The method of claim 3 , wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction.

21. The method of claim 4 , wherein the pre-existing left ventricular dysfunction of (b) is characterized by systolic dysfunction.

22. The method of claim 1 , wherein the pediatric patient is a neonate.

23. The method of claim 2 , wherein the pediatric patient is a neonate.

24. The method of claim 3 , wherein the pediatric patient is a neonate.

25. The method of claim 1 , wherein the pediatric patient is 4 weeks to 18 years of age.

26. The method of claim 2 , wherein the pediatric patient is 4 weeks to 18 years of age.

27. The method of claim 3 , wherein the pediatric patient is 4 weeks to 18 years of age.

28. The method of claim 22 , wherein the neonate has persistent pulmonary h

Assignees

• Mallinckrodt Hospital Products Ip Ltd

Inventors

• Baldassarre James S

Classifications

• A61K33/00 Primary

  Medicinal preparations containing inorganic active ingredients · CPC title

• A61B5/02007

  Evaluating blood vessel condition, e.g. elasticity, compliance · CPC title

• A61B5/0205

  Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition · CPC title

• A61B5/08

  Measuring devices for evaluating the respiratory organs · CPC title

• A61B5/4839

  combined with drug delivery · CPC title