Methods for monitoring severity of panic attacks and other rapidly evolving medical events in real time

• US 20050131739A1
• Filed: 11/23/2004
• Published: 06/16/2005
• Est. Priority Date: 12/16/2003
• Status: Abandoned Application

• Current Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Original Assignee: Alexza Molecular Delivery Corporation (Grupo Ferrer Internacional SA)
• Inventors: Rabinowitz, Joshua D., Skowronski, Roman
• Application Number:
  US10/996,114
• Publication Number:
  US 20050131739A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: A61B 5/16 Devices for psychotechnics using teaching or educational appliances G09B1/00 - G09B7/00; Testing reaction times ; Devices for evaluating the psychological state
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: G06Q 10/109 Time management, e.g. calendars, reminders, meetings or time accounting
• CPC Class Codes: G16H 40/63 for local operation

Abstract

The present invention provides novel methods of recording a medical event in real-time. One aspect of the invention comprises providing a subject an electronic diary for recording one or more aspects of a medical event, wherein the diary electronically records a time at which entries to the diary are made without requiring the subject to input the time of each entry and wherein the diary further prompts the subject to make an entry in the diary at various time intervals. Other aspects of the invention include methods of determining whether a medical treatment produces a therapeutic effect in a subject using real-time data; methods of measuring response of a subject experiencing panic attack symptoms to a treatment in real-time; and methods of assessing the relative effectiveness in real-time of a first medical treatment and a second medical treatment.

Claims

1. A method of recording a medical event in real-time comprising providing a subject an electronic diary for recording one or more aspects of the medical event, wherein the diary electronically records a time at which entries to the diary are made without requiring the subject to input the time of each entry and wherein the diary further prompts the subject to make an entry in the diary at least twice within every 54 minute time period, following activation of the diary by the subject upon the initiation of the medical event, and continuing until deactivation of prompting from the diary.

2. The method of claim 1, wherein the diary prompts the subject to make an entry at least twice within every 18 minute time period.

3. The method of claim 2, wherein the diary prompts the subject to make an entry at least three times within every 18 minute time period.

4. The method of claim 1, wherein at least one aspect of the medical event is recorded on at least one scale.

5. The method of claim 4, wherein the diary prompts the subject to record at least one entry on the at least one scale at least two times within every 12 minute time period.

6. The method of claim 5, wherein the diary, at a pre-determined time interval of less than or equal to six minutes, prompts the subject to record at least one entry on the at least one scale.

7. The method of claim 6, wherein the diary, at a pre-determined time interval of less than or equal to every three minutes, prompts the subject to record at least one entry on at least one scale.

8. The method of claim 4, wherein the at least one scale comprises a visual-analogue scale.

9. The method of claim 8, wherein the visual-analogue scale has between 6 and 12 points.

10. The method of claim 9, wherein the visual-analogue scale measures the severity of panic.

11. A method of recording a panic attack in real-time comprising providing a subject an electronic diary for recording one or more aspect of the panic attack, wherein the subject records an entry in the diary at least three times within every 36 minute time period until deactivation of the diary.

12. The method of claim 11, wherein the subject experiencing the panic attack makes the entry in the diary.

13. The method of claim 12, wherein the at least three entries are made within every 18 minute time period.

14. The method of claim 12, wherein the diary prompts the subject to make entries in response to the subject activating the diary upon initiation of an attack.

15. The method of claim 14, wherein the diary prompts the subject to make an entry at a pre-determined time interval of less than or equal to every six minutes.

16. The method of claim 15, wherein the diary prompts the subject at a pre-determined time interval of less than or equal to every three minutes.

17. The method of claim 11, wherein the entry in the diary comprises a score on a scale.

18. The method of claim 17, wherein the entry in the diary comprises a score on a visual analogue scale.

19. The method of claim 18, wherein the visual-analogue scale has between 6 and 12 points.

20. The method of claim 19, wherein the visual-analogue scale has 11 points.

21. The method of claim 20, wherein the 11 points range from 0 to 10.

22. The method of claim 17, wherein the score indicates severity of the subject'"'"'s panic symptoms when the entry is made in the diary.

23. The method of claim 22, wherein the diary automatically records a time when each entry is made in the diary.

24. A method of determining whether a medical treatment produces a therapeutic effect in a subject using real-time data comprising:

(a) providing the subject an electronic diary,

(b) administering the medical treatment to the subject, and

(c) prompting the subject to enter in the diary at least one measure for symptoms being experienced by the subject at least twice within every 54 minute time period after administration of the medical treatment until deactivation of prompting.

25. The method of claim 24, further comprising the subject recording an entry in the diary, of at least one measure for the symptoms being experienced, prior to administration of the medical treatment.

26. The method of claim 25, wherein the subject is prompted to make an entry at least once every 12 minutes after the administration of the medical treatment.

27. The method of claim 26, wherein the subject is prompted to make an entry at least three times every 24 minutes after administration of the medical treatment.

28. The method of claim 27, wherein the subject is prompted to make an entry at least once every six minutes.

29. The method of claim 28, wherein the subject is prompted to make an entry at least once every three minutes.

30. The method of claim 25, wherein the at least one measure of the symptoms comprises a score on a scale.

31. The method of claim 30, wherein the at least one measure of symptoms comprises a score on a visual analogue scale.

32. The method of claim 30, wherein the score indicates the severity of panic symptoms of the subject.

33. The method of claim 25, wherein the subject self administers the medical treatment.

34. The method of claim 24, wherein the medical treatment comprises administering a drug to a subject.

35. The method of claim 34, wherein the administering results in maximal plasma drug concentrations in the subject within 54 minutes.

36. The method of claim 34, wherein the drug is administered by inhalation.

37. The method of claim 36, wherein the drug is in the form of an aerosol characterized by a mass median aerodynamic diameter of less than 3 micrometers.

38. The method of claim 35, wherein the drug has sedative properties.

39. The method of claim 38, wherein the drug is a benzodiazepine.

40. The method of claim 39, wherein the drug is alprazolam.

41. A method of measuring response of a subject experiencing panic attack symptoms to a treatment in real-time comprising:

(a) providing the subject that experiences panic attack symptoms an electronic diary,

(b) administering the treatment to the subject when the panic attack symptoms are present, and

(c) entering in the diary at least one measure of the symptoms at least twice every 18 minutes after administration of the treatment until deactivation of the diary.

42. The method of claim 41, further comprising entering in the diary at least one measure of the panic attack symptoms prior to administration of the treatment.

43. The method of claim 41, further comprising entering in the diary at least one measure of the panic attack symptoms at least three times every 18 minutes after administration of the treatment.

44. The method of claim 43, wherein the diary prompts the subject to make an entry at least once every 6 minutes after administration of the treatment.

45. The method of claim 44, wherein the diary prompts the subject to make an entry at least once every 3 minutes after administration of the treatment.

46. The method of claim 41, wherein the at least one measure of the symptoms comprises a score on a scale.

47. The method of claim 46, wherein the at least one measure of symptoms comprises a score on a visual analogue scale.

48. The method of claim 47, wherein the visual analogue scale has between 6 and 12 points.

49. The method of claim 46, wherein the score indicates a self-assessment by the subject of the severity of the subject'"'"'s panic symptoms.

50. The method of claim 41, wherein the subject self administers the treatment.

51. The method of claim 50, wherein the treatment comprises administering a drug to a subject.

52. The method of claim 51 wherein the drug is administered by inhalation.

53. The method of claim 52, wherein the drug is in the form of an aerosol characterized by a mass median aerodynamic diameter of less than 5 micrometers.

54. The method of claim 51, wherein the drug enhances GABA-type neurotransmission.

55. The method of claim 54, wherein the drug is a benzodiazepine.

56. The method of claim 55, wherein the drug is alprazolam.

57. The method of claim 41, wherein administration of the medical treatment occurs within 6 minutes of identification of the presence of panic attack symptoms.

58. A method of assessing the relative effectiveness of a first medical treatment and a second medical treatment comprising:

(a) providing an electron diary to a first subject that experiences one or more symptoms to be treated,

(b) administering the first medical treatment to the subject experiencing one or more of the symptoms to be treated,

(c) entering in the electronic diary in real-time at least one measure of symptoms at least twice every 54 minute time period after administration of the medical treatment until deactivation of the diary,

d) repeating the above steps (a)-(c) for the second medical treatment with the first subject or a second subject, and

e) comparing diary entries made after administration of the first medical treatment with entries made after administration of the second medical treatment.

59. The method of claim 58, further comprising recording in the diary at least one measure of the symptoms prior to administration of the medical treatments.

60. The method of claim 59, further comprising entering in the diary at least one measure of the symptoms at least three times every 18 minutes after administration of the medical treatments.

61. The method of claim 60, wherein the diary prompts the subject to make an entry at least once every 6 minutes after administration of the medical treatments.

62. The method of claim 61, wherein the at least one measure of the symptoms comprises a score on a scale.

63. The method of claim 62, wherein the at least one measure of symptoms comprises a score on a visual analogue scale.

64. The method of claim 62, wherein the score indicates the severity of panic symptoms.

65. The method of claim 62, wherein a subject who receives the first medical treatment also receives the second medical treatment.

66. The method of claim 62, wherein the first medical treatment comprises a placebo and the second medical treatment comprises a drug.

67. The method of claim 62, wherein subjects are randomly assigned to receive the first or the second medical treatment.

68. The method of claim 67, wherein comparing entries made in the diary after administration of the first medical treatment with entries made in the diary after administration of the second medical treatment comprises use of a statistical test.

69. The method of claim 68, wherein the number of subjects receiving the first and the second medical treatments is selected such that a clinically relevant difference between the treatments has a greater than 50% probability of resulting in a p-value of less than 0.05 in the statistical test.

70. A method of determining whether a drug composition is more effective in treating panic than a placebo composition comprising:

(a) providing a diary to a first subject that has been identified as having had the presence of panic attack symptoms;

(b) administering to the first subject experiencing the panic attack symptoms the placebo composition;

(c) entering in the diary a score on a scale that measures panic attack symptoms at least three times every 18 minutes after administration of the placebo composition until deactivation of the diary;

(d) repeating the above steps (a)-(c) for the drug composition with the first subject or with a second subject,

(e) comparing the scores entered after administration of the drug composition with the scores entered after administration of the placebo composition and/or the duration of the event after administration of the drug composition with the duration of the event after administration of the of the placebo composition, and

(f) correlating a decrease in the duration of the event or in the scores of the symptoms after administration of the drug composition relative to the placebo composition with more effectiveness of the drug than the placebo in treating panic.

71. The method of claim 70, further comprising repeating steps (a)-(f) for at least ten discrete first subjects receiving the placebo composition and at least ten discrete second subjects receiving the drug composition.

72. The method of claim 71, wherein comparing the scores entered after administration of the drug composition with the scores entered after administration of the placebo composition comprises determining whether the drug composition resulted in a statistically significantly different scores than the placebo composition.

73. The method of claim 72, wherein the drug composition comprises a benzodiazepine.

74. The method of claim 73, wherein the drug composition comprises alprazolam or clonazepam.

75. The method of claim 75, wherein administering the drug composition comprises the patient inspiring an aerosol.