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1. (WO2019006534) PROBIOTIC-BASED TREATMENT OF RESISTANT CHRONIC RHINOSINUSITIS
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WHAT IS CLAIMED IS:

1 . A method of treating a patient suffering from steroid-resistant chronic rhinosinusitis (CRS), said method comprising administering to a sinus from said subject (i) a composition comprising an effective amount of probiotics; and (ii) an effective amount of an anti-inflammatory agent.

2. A method of improving or restoring the response to sinus treatment with an antiinflammatory agent in a patient suffering from steroid-resistant chronic rhinosinusitis (CRS), said method comprising administering to a sinus from said subject a composition comprising an effective amount of probiotics.

3. The method of claim 1 or 2, wherein said anti-inflammatory agent is a steroid.

4. The method of claim 3, wherein said steroid is a corticosteroid.

5. The method of claim 4, wherein said corticosteroid is budenoside.

6. The method of any one of claims 1 to 5, wherein the administering is by sinus rinse or irrigation.

7. The method of any one of claims 1 to 6, wherein said composition comprises a mixture of different probiotic strains.

8. The method of any one of claims 1 to 6, wherein said composition comprises a single probiotic strain.

9. The method of any one of claims 1 to 8, wherein said probiotics comprise Gram-positive bacteria.

10. The method of claim 9, wherein said Gram-positive bacteria are lactic acid bacteria (LAB).

1 1 . The method of claim 10, wherein said LAB is of the lactococcus genus.

12. The method of claim 1 1 , wherein said LAB of the lactococcus genus is lactococcus lactis,

13. The method of claim 12, wherein said lactococcus lactis is lactococcus lactis subsp. cremoris.

14. The method of any one of claims 1 to 13, wherein the composition comprising probiotics is administered twice-daily.

15. The method of any one of claims 1 to 14, wherein the composition comprising probiotics is administered for a period of at least two weeks.

16. The method of claim 15, wherein the composition comprising probiotics is administered for a period of about 3 to 5 weeks.

17. The method of any one of claims 1 to 16, wherein the probiotics are present in an amount corresponding to at least about 106 colony-forming units (CFU) in said composition. 18. The method of claim 17, wherein the probiotics are present in an amount corresponding to about 108 to about 1012 CFU in said composition.

19. The method of any one of claims 1 to 18, wherein the composition comprising probiotics is a liquid composition and comprises a concentration of probiotics of at least about 105 CFU/mL.

20. The method of claim 19, wherein the concentration of probiotics is about 106 to aboutl 08 CFU/mL.

21 . The method of claim 19 or 20, wherein the liquid composition comprises a saline buffer.

22. The method of claim 21 , wherein said method further comprises resuspending said probiotics in said saline buffer prior to administration.

23. The method of any one of claims 1 to 22, wherein said probiotics and said antiinflammatory agent are in different compositions.

24. The method of any one of claims 1 to 23, wherein said method improves at least one of the following CRS symptom parameters in said subject: sino-nasal symptom score (SNSS), Sino-nasal Outcome test 22 items (SNOT-22) score and/or peri-operative sinus endoscopy (POSE) score.

25. The method of claim 24, wherein said method improves all of the following CRS symptom parameters in said subject: SNSS, SNOT-22 score, and POSE score.

26. The method of any one of claims 1 to 25, wherein said steroid-resistant CRS is steroid-resistant CRS with nasal polyps.

27. The method of any one of claims 1 to 26, wherein said steroid-resistant CRS is refractory CRS.

28. Use of (i) a composition comprising an effective amount of probiotics; and (ii) an effective amount of an anti-inflammatory agent, for treating a patient suffering from steroid-resistant CRS, wherein said composition comprising an effective amount of probiotics and said anti-inflammatory agent are for sinus administration.

29. Use of (i) a composition comprising an effective amount of probiotics; and (ii) an effective amount of an anti-inflammatory agent, for the manufacture of a medicament for treating a patient suffering from steroid-resistant CRS, wherein said composition comprising an effective amount of probiotics and said anti-inflammatory agent are for sinus administration.

30. A combination for treating a patient suffering from steroid-resistant CRS, said combination comprising (i) a composition comprising an effective amount of probiotics; and (ii) an effective amount of an anti-inflammatory agent, wherein said composition comprising an effective amount of probiotics and said anti-inflammatory agent are for sinus administration.

31 . Use of a composition comprising an effective amount of probiotics for improving or restoring the response to anti-inflammatory sinus treatment in a patient suffering from steroid-resistant CRS, wherein said composition is for sinus administration.

32. Use of a composition comprising an effective amount of probiotics for the manufacture of a medicament for improving or restoring the response to anti-inflammatory sinus treatment in a patient suffering from steroid-resistant CRS, wherein said composition is for sinus administration.

33. A composition comprising an effective amount of probiotics for improving or restoring the response to anti-inflammatory sinus treatment in a patient suffering from steroid-resistant CRS, wherein said composition is for sinus administration.

34. The use or composition for use according to any one of claims 28 to 33, wherein said anti-inflammatory agent is a steroid.

35. The use or composition for use according to claim 34, wherein said steroid is a corticosteroid.

36. The use or composition for use according to claim 35, wherein said corticosteroid is budenoside.

37. The use or composition for use according to any one of claims 28 to 36, wherein the sinus administration is sinus rinse or irrigation.

38. The use or composition for use according to any one of claims 28 to 37, wherein said composition comprises a mixture of different probiotic strains.

39. The use or composition for use according to any one of claims 28 to 38, wherein said composition comprises a single probiotic strain.

40. The use or composition for use according to any one of claims 28 to 39, wherein said probiotics comprise Gram-positive bacteria.

41 . The use or composition for use according to claim 40, wherein said Gram-positive bacteria are lactic acid bacteria (LAB).

42. The use or composition for use according to claim 41 , wherein said LAB is of the lactococcus genus.

43. The use or composition for use according to claim 42, wherein said LAB of the lactococcus genus is lactococcus lactis.

44. The use or composition for use according to claim 43, wherein said lactococcus lactis is lactococcus lactis subsp. cremoris.

45. The use or composition for use according to any one of claims 28 to 44, wherein the composition comprising probiotics is for twice-daily administration.

46. The use or composition for use according to any one of claims 28 to 45, wherein the composition comprising probiotics is for administration for a period of at least two weeks.

47. The use or composition for use according to claim 46, wherein the composition comprising probiotics is for administration for a period of about 3 to 5 weeks.

48. The use or composition for use according to any one of claims 28 to 47, wherein the probiotics are present in an amount corresponding to at least about 106 colony-forming units (CFU) in said composition.

49. The use or composition for use according to claim 48, wherein the probiotics are present in an amount corresponding to about 108 to about 1012 CFU in said composition.

50. The use or composition for use according to any one of claims 28 to 50, wherein the composition comprising probiotics is a liquid composition and comprises a concentration of probiotics of at least about 105 CFU/mL.

51 . The use or composition for use according to claim 50, wherein the concentration of probiotics is about 106 to about 108 CFU/mL.

52. The use or composition for use according to claim 50 or 51 , wherein the liquid composition comprises a saline buffer.

53. The use or composition for use according to claim 52, wherein said method further comprises resuspending said probiotics in said saline buffer prior to said use.

54. The use or composition for use according to any one of claims 28 to 53, wherein said probiotics and said anti-inflammatory agent are in different compositions.

55. The use or composition for use according to any one of claims 28 to 54, wherein said use improves at least one of the following CRS symptom parameters in said subject: sino-nasal symptom score (SNSS), Sino-nasal Outcome test 22 items (SNOT-22) score and/or perioperative sinus endoscopy (POSE) score.

56. The use or composition for use according to claim 55, wherein said use improves all of the following CRS symptom parameters in said subject: SNSS, SNOT-22 score, and POSE score.

57. The use or composition for use according to any one of claims 28 to 56, wherein said steroid-resistant CRS is steroid-resistant CRS with nasal polyps.

58. The use or composition for use according to any one of claims 28 to 57, wherein said steroid-resistant CRS is refractory CRS.

59. A kit or package for treating steroid-resistant CRS in a patient, for improving or restoring the response to anti-inflammatory treatment in a steroid-resistant CRS patient, said kit or package comprising a composition comprising an effective amount of probiotics and instructions setting forth the method of any one of claims 1 to 27.

60. The kit or package of claim 59, wherein the composition comprising probiotics is lyophilized, spray-dried or freeze-dried.

61 . The kit or package of claim 60, further comprising a solution for reconstituting said composition comprising probiotics.

62. The kit or package of any one of claims 59 to 61 , further comprising an anti-inflammatory agent.

63. The kit or package of any one of claims 59 to 62, further comprising a device or system for sinus rinse or sinus irrigation.

64. The kit or package of any one of claims 59 to 62, comprising one of more of the features defined in any one of claims 3 to 27.