Claims for Patent: 12,616,806

Summary for Patent: 12,616,806

Title:	Nasal administration
Abstract:	A method of delivering a substance, such as one or more of a triptan, a nasal steroid or carbon dioxide gas, to the nasal cavity of a subject, in particular for the treatment of headaches, for example, migraine, or rhinosinusitis, for example, chronic rhinosinusitis, optionally with polyps, the method comprising the steps of fitting a nosepiece to one nostril of the subject, delivering the substance through the nosepiece to the posterior region of the nasal cavity of the subject.
Inventor(s):	Per Gisle Djupesland, Ramy A. Mahmoud, John Messina
Assignee:	Optinose Inc
Application Number:	US18/079,334
Patent Claims:	1. A method of treating chronic rhinosinusitis with nasal polyps in a patient comprising: placing a nosepiece of a housing into a first nostril of the patient; placing a mouthpiece of the housing into a mouth of the patient, the mouthpiece being fluidly connected to the nosepiece by a flow path, wherein exhalation by the patient into the mouthpiece and out of the nosepiece produces a bi-directional fluid flow of exhalation air into a first nasal passageway of the patient and out of a second nasal passageway of the patient; manually depressing a chamber with the patient's thumb or finger to activate a pump and flow fluticasone propionate from the chamber to the nosepiece; opening a valve in the flow path from the mouthpiece to the nosepiece in response to manually depressing the chamber; administering fluticasone propionate as a liquid aerosol during exhalation by the patient through the nosepiece; delivering carbon dioxide during exhalation by the patient through the nosepiece, to a location at an upper posterior region of the first nasal passageway of the patient; and reducing a pH at the location at the upper posterior region of the first nasal passageway of the patient by an amount ranging from about 0.1 pH units to about 0.2 pH units by controlling the fluid flow to deliver the carbon dioxide at a concentration of from about 5% vol/vol to about 6% vol/vol carbon dioxide and at a fluid flow rate of at least 20 L/min for a duration of from about 2 seconds to about 3 seconds, wherein the carbon dioxide is delivered before or at the same time as the fluticasone propionate. 2. The method of claim 1, wherein the fluticasone propionate is administered in an amount of about 400 μg b.i.d. 3. The method of claim 1, wherein the fluticasone propionate is administered in an amount of about 200 μg b.i.d. 4. The method of claim 1, wherein the fluticasone propionate is administered in an amount of 100 to 400 μg b.i.d. 5. The method of claim 1, wherein the fluid flow is delivered as a burst of air on opening of the valve. 6. The method of claim 1, wherein the chamber, pump and nosepiece are axially aligned. 7. The method of claim 1, further comprising flowing the fluticasone propionate through a nozzle proximate the nosepiece during exhalation by the patient. 8. The method of claim 1, wherein the administering of the fluticasone propionate further comprises simultaneously delivering the fluticasone propionate and exhalation air to the first nasal passageway. 9. The method of claim 1, wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing. 10. The method of claim 1, further comprising flowing the exhalation air through a delivery channel of the flow path that extends from the valve towards the nosepiece. 11. The method of claim 10, wherein the delivery channel inwardly tapers as the delivery channel extends from the valve towards the nosepiece. 12. The method of claim 5, further comprising flowing the exhalation air through a delivery channel of the flow path that extends from the valve towards the nosepiece. 13. The method of claim 12, wherein the delivery channel inwardly tapers as the delivery channel extends from the valve towards the nosepiece. 14. The method of claim 6, wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing. 15. The method of claim 12, further comprising flowing the fluticasone propionate through a nozzle proximate the nosepiece during exhalation by the patient, wherein the administering of the fluticasone propionate further comprises simultaneously delivering the fluticasone propionate and exhalation air to the first nasal passageway. 16. The method of claim 12, wherein the fluticasone propionate is administered in an amount of about 400 μg b.i.d. 17. The method of claim 12, wherein the fluticasone propionate is administered in an amount of about 200 μg b.i.d. 18. The method of claim 12, wherein the fluticasone propionate is administered in an amount of 100 to 400 μg b.i.d. 19. The method of claim 14, wherein the fluticasone propionate is administered in an amount of about 400 μg b.i.d. 20. The method of claim 14, wherein the fluticasone propionate is administered in an amount of about 200 μg b.i.d. 21. The method of claim 14, wherein the fluticasone propionate is administered in an amount of 100 to 400 μg b.i.d. 22. A method of treating chronic rhinosinusitis without nasal polyps in a patient comprising: placing a nosepiece of a housing into a first nostril of the patient; placing a mouthpiece of the housing into a mouth of the patient, the mouthpiece being fluidly connected to the nosepiece by a flow path, wherein exhalation by the patient into the mouthpiece and out of the nosepiece produces a bi-directional fluid flow of exhalation air into a first nasal passageway of the patient and out of a second nasal passageway of the patient; manually depressing a chamber with the patient's thumb or finger to activate a pump and flow fluticasone propionate from the chamber to the nosepiece; opening a valve in the flow path from the mouthpiece to the nosepiece in response to manually depressing the chamber; administering fluticasone propionate as a liquid aerosol during exhalation by the patient through the nosepiece; delivering carbon dioxide during exhalation by the patient through the nosepiece, to a location at an upper posterior region of the first nasal passageway of the patient; and reducing a pH at the location at the upper posterior region of the first nasal passageway of the patient by an amount ranging from about 0.1 pH units to about 0.2 pH units by controlling the fluid flow to deliver the carbon dioxide at a concentration of from about 5% vol/vol to about 6% vol/vol carbon dioxide and at a fluid flow rate of at least 20 L/min for a duration of from about 2 seconds to about 3 seconds, wherein the carbon dioxide is delivered before or at the same time as the fluticasone propionate. 23. The method of claim 22, wherein the fluticasone propionate is administered in an amount of about 400 μg b.i.d. 24. The method of claim 22, wherein the fluticasone propionate is administered in an amount of about 200 μg b.i.d. 25. The method of claim 22, wherein the fluticasone propionate is administered in an amount of 100 to 400 μg b.i.d. 26. The method of claim 22, wherein the fluid flow is delivered as a burst of air on opening of the valve. 27. The method of claim 22, wherein the chamber, pump and nosepiece are axially aligned. 28. The method of claim 22, further comprising flowing the fluticasone propionate through a nozzle proximate the nosepiece during exhalation by the patient. 29. The method of claim 22, wherein the administering of the fluticasone propionate further comprises simultaneously delivering the fluticasone propionate and exhalation air to the first nasal passageway. 30. The method of claim 22, wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing. 31. The method of claim 22, further comprising flowing the exhalation air through a delivery channel of the flow path that extends from the valve towards the nosepiece. 32. The method of claim 31, wherein the delivery channel inwardly tapers as the delivery channel extends from the valve towards the nosepiece. 33. The method of claim 26, further comprising flowing the exhalation air through a delivery channel of the flow path that extends from the valve towards the nosepiece. 34. The method of claim 33, wherein the delivery channel inwardly tapers as the delivery channel extends from the valve towards the nosepiece. 35. The method of claim 27, wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing. 36. The method of claim 33, further comprising flowing the fluticasone propionate through a nozzle proximate the nosepiece during exhalation by the patient, wherein the administering of the fluticasone propionate further comprises simultaneously delivering the fluticasone propionate and exhalation air to the first nasal passageway. 37. The method of claim 33, wherein the fluticasone propionate is administered in an amount of about 400 μg b.i.d. 38. The method of claim 33, wherein the fluticasone propionate is administered in an amount of about 200 μg b.i.d. 39. The method of claim 33, wherein the fluticasone propionate is administered in an amount of 100 to 400 μg b.i.d. 40. The method of claim 35, wherein the fluticasone propionate is administered in an amount of about 400 μg b.i.d. 41. The method of claim 35, wherein the fluticasone propionate is administered in an amount of about 200 μg b.i.d. 42. The method of claim 35, wherein the fluticasone propionate is administered in an amount of 100 to 400 μg b.i.d. 43. A method of treating chronic rhinosinusitis with nasal polyps in a patient comprising: placing a nosepiece of a housing into a first nostril of the patient; placing a mouthpiece of the housing into a mouth of the patient, the mouthpiece being fluidly connected to the nosepiece by a flow path, wherein exhalation by the patient into the mouthpiece and out of the nosepiece produces a bi-directional fluid flow of exhalation air into a first nasal passageway of the patient and out of a second nasal passageway of the patient; manually depressing a chamber with the patient's thumb or finger to activate a pump and flow fluticasone propionate from the chamber to the nosepiece, wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing; opening a valve in the flow path from the mouthpiece to the nosepiece in response to manually depressing the chamber; administering fluticasone propionate as a liquid aerosol during exhalation by the patient through the nosepiece; delivering carbon dioxide during exhalation by the patient through the nosepiece, to a location at an upper posterior region of the first nasal passageway of the patient; and reducing a pH at the location at the upper posterior region of the first nasal passageway of the patient by an amount ranging from about 0.1 pH units to about 0.2 pH units by controlling the fluid flow to deliver the carbon dioxide at a concentration of from about 5% vol/vol to about 6% vol/vol carbon dioxide and at a fluid flow rate of at least 20 L/min for a duration of from about 2 seconds to about 3 seconds, wherein the carbon dioxide is delivered before or at the same time as the fluticasone propionate, wherein: the chamber, pump and nosepiece are axially aligned; the flow path includes a delivery channel which inwardly tapers as the delivery channel extends from the valve towards the nosepiece; and the administering of the fluticasone propionate further comprises simultaneously delivering the fluticasone propionate and exhalation air to the first nasal passageway. 44. The method of claim 43, wherein the fluticasone propionate is administered in an amount of about 400 μg b.i.d. 45. The method of claim 43, wherein the fluticasone propionate is administered in an amount of about 200 μg b.i.d. 46. The method of claim 43, wherein the fluticasone propionate is administered in an amount of 100 to 400 μg b.i.d. 47. The method of claim 43, wherein the fluid flow is delivered as a burst of air on opening of the valve. 48. The method of claim 43, further comprising flowing the fluticasone propionate through a nozzle proximate the nosepiece during exhalation by the patient. 49. The method of claim 43, further comprising flowing the exhalation air through the delivery channel of the flow path that extends from the valve towards the nosepiece. 50. A method of treating chronic rhinosinusitis without nasal polyps in a patient comprising: placing a nosepiece of a housing into a first nostril of the patient; placing a mouthpiece of the housing into a mouth of the patient, the mouthpiece being fluidly connected to the nosepiece by a flow path, wherein exhalation by the patient into the mouthpiece and out of the nosepiece produces a bi-directional fluid flow of exhalation air into a first nasal passageway of the patient and out of a second nasal passageway of the patient; manually depressing a chamber with the patient's thumb or finger to activate a pump and flow fluticasone propionate from the chamber to the nosepiece, wherein the manually depressing of the chamber further comprises axially moving the chamber within an aperture in the housing; opening a valve in the flow path from the mouthpiece to the nosepiece in response to manually depressing the chamber; administering fluticasone propionate as a liquid aerosol during exhalation by the patient through the nosepiece; delivering carbon dioxide during exhalation by the patient through the nosepiece, to a location at an upper posterior region of the first nasal passageway of the patient; and reducing a pH at the location at the upper posterior region of the first nasal passageway of the patient by an amount ranging from about 0.1 pH units to about 0.2 pH units by controlling the fluid flow to deliver the carbon dioxide at a concentration of from about 5% vol/vol to about 6% vol/vol carbon dioxide and at a fluid flow rate of at least 20 L/min for a duration of from about 2 seconds to about 3 seconds, wherein the carbon dioxide is delivered before or at the same time as the fluticasone propionate, wherein: the chamber, pump and nosepiece are axially aligned; the flow path includes a delivery channel which inwardly tapers as the delivery channel extends from the valve towards the nosepiece; and the administering of the fluticasone propionate further comprises simultaneously delivering the fluticasone propionate and exhalation air to the first nasal passageway. 51. The method of claim 50, wherein the fluticasone propionate is administered in an amount of about 400 μg b.i.d. 52. The method of claim 50, wherein the fluticasone propionate is administered in an amount of about 200 μg b.i.d. 53. The method of claim 50, wherein the fluticasone propionate is administered in an amount of 100 to 400 μg b.i.d. 54. The method of claim 50, wherein the fluid flow is delivered as a burst of air on opening of the valve. 55. The method of claim 50, further comprising flowing the fluticasone propionate through a nozzle proximate the nosepiece during exhalation by the patient. 56. The method of claim 50, further comprising flowing the exhalation air through the delivery channel of the flow path that extends from the valve towards the nosepiece.