Methods for treating and preventing symptoms of asthma with a corticosteroid pharmaceutical composition

Abstract

A method is provided for treating or preventing symptoms of asthma in a subject in need thereof by administering a corticosteroid pharmaceutical composition to a subject qualified for over-the-counter access to the corticosteroid pharmaceutical composition. In some embodiments, the corticosteroid pharmaceutical composition includes a class B corticosteroid, a glucocorticosteroid, budesonide, ciclesonide, fluticasone furoate, mometasone furoate, fluticasone propionate, or beclomethasone dipropionate.

What is claimed is: 
     
         1 . A computer system for qualifying a human subject for over-the-counter delivery of a corticosteroid pharmaceutical composition for treating or preventing symptoms of asthma, the computer system comprising one or more processors and a memory, the memory comprising non-transitory instructions which, when executed by the one or more processor, perform a method comprising:
 a) conducting a first survey of the subject thereby obtaining a first plurality of survey results, wherein the first plurality of survey results indicates:
 whether the subject is taking another steroid medication, 
 an age of the subject, 
 a pulmonary function status of the subject, 
 a severity of the subject's asthma, 
 whether the subject has an untreated infection, 
 a surgery status of the subject, 
 a bone density status of the subject, and 
 whether the subject has ever had cataracts or glaucoma; 
   b) running all or a portion of the first plurality of survey results against a first plurality of filters of a first category class, wherein, when a respective filter in the first plurality of filters is fired, the subject is deemed not qualified for delivery of the corticosteroid pharmaceutical composition and the method is terminated without delivery of the corticosteroid pharmaceutical composition to the subject, wherein the first plurality of filters comprises:
 a first steroid medication filter that is fired at least when the first plurality of survey results indicates that the subject is taking a steroid medication, 
 an age filter, 
 a first pulmonary function filter that is fired at least when the first plurality of survey results indicates that the subject has compromised pulmonary function, and 
 an asthma severity filter; 
   c) running all or a portion of the first plurality of survey results against a second plurality of filters of a second category class, wherein, when a respective filter in the second plurality of filters is fired, the subject is provided with a warning corresponding to the respective filter, and wherein the second plurality of filters comprises:
 a first infection filter that is fired at least when the first plurality of survey results indicates that the subject has a severe, untreated infection, 
 a first surgery filter that is fired at least when the first plurality of survey results indicates that the subject is planning on undergoing surgery, 
 a first bone density filter that is fired at least when the first plurality of survey results indicates that the subject has decreased bone mineral density, and 
 a first ocular disease filter that is fired at least when the first plurality of survey results indicates that the subject has ever had cataracts or glaucoma; 
   d) obtaining acknowledgment from the subject for the warning issued to the subject by any filter in the second plurality of filters; and   e) proceeding with a fulfillment process when (i) no filter in the first plurality of filters has been fired and (ii) the subject has acknowledged each warning associated with each filter in the second plurality of filters that was fired, wherein the fulfillment process comprises:
 storing an indication in a subject profile of an initial order for the corticosteroid pharmaceutical composition, 
 communicating an over the counter drug facts label for the corticosteroid pharmaceutical composition to the subject, and 
 authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, provision of the corticosteroid pharmaceutical composition to the subject. 
   
     
     
         2 . The computer system of  claim 1 , wherein the corticosteroid pharmaceutical composition includes a class B corticosteroid. 
     
     
         3 . The computer system of  claim 1  wherein the corticosteroid pharmaceutical composition includes a glucocorticosteroid. 
     
     
         4 . The computer system of  claim 1 , wherein the corticosteroid pharmaceutical composition includes budesonide as an active ingredient. 
     
     
         5 . The computer system of  claim 4 , wherein, upon satisfying the requirements of the survey, the subject is authorized for a dosage of 90 mcg to 270 mcg of budesonide twice daily. 
     
     
         6 . The computer system of  claim 4 , wherein, upon satisfying the requirements of the survey, the subject is authorized for a dosage of 180 mcg of budesonide twice daily. 
     
     
         7 . The computer system of  claim 1 , wherein the corticosteroid pharmaceutical composition includes a composition selected from the group consisting of ciclesonide, fluticasone furoate, mometasone furoate, fluticasone propionate, and beclomethasone dipropionate. 
     
     
         8 . The computer system according to any one of  claims 1 - 7 , wherein the age filter is fired when the first plurality of survey results indicates that the subject is less than eighteen years old. 
     
     
         9 . The computer system according to any one of  claims 1 - 8 , wherein the compromised pulmonary function, capable of firing the first pulmonary filter, is a forced expiratory volume measured over one second (FEV1) of no more than 80% of a predicted volume for the subject. 
     
     
         10 . The computer system according to any one of  claims 1 - 9 , wherein:
 the first plurality of survey results further comprises an asthma severity status of the subject, and   the first plurality of filters includes a first asthma filter that is fired when the first plurality of survey results indicates that the subject has severe asthma.   
     
     
         11 . The computer system according to any one of  claims 1 - 9 , wherein:
 the first plurality of survey results further comprises how frequently the subject experiences symptoms of asthma, wherein:
 an infrequency with which the subject experiences symptoms of asthma, which is capable of firing the first asthma filter, is less than twice a week, and 
 a frequency with which the subject experiences symptoms of asthma, which is capable of firing the first asthma filter, is more than six times a week. 
   
     
     
         12 . The computer system according to any one of  claims 1 - 9 , wherein:
 the first plurality of survey results further comprises how frequently symptoms of asthma disrupt the subject's sleep, wherein:
 an infrequency with which the subject's sleep is disrupted by symptoms of asthma, which is capable of firing the first asthma filter, is less than three times a month, and 
 a frequency with which the subject's sleep is disrupted by symptoms of asthma, which is capable of firing the first asthma filter, is more than four times a month. 
   
     
     
         13 . The computer system according to any one of  claims 1 - 9 , wherein:
 the first plurality of survey results further comprises how frequently the subject uses a rescue inhaler, wherein:
 an infrequency with which the subject uses a rescue inhaler, which is capable of firing the first asthma filter, is less than twice a week, and 
 a frequency with which the subject uses a rescue inhaler, which is capable of firing the first asthma filter, is more than six times a week. 
   
     
     
         14 . The computer system according to any one of  claims 1 - 9 , wherein:
 the first plurality of survey results further comprises how frequently the subject uses oral steroids, wherein a frequency with which the subject has used oral steroids, which is capable of firing the first asthma filter, is more than once in the past year.   
     
     
         15 . The computer system according to any one of  claims 1 - 14  wherein:
 the corticosteroid pharmaceutical composition comprises budesonide; 
 the first plurality of survey results further indicates: whether the subject has a dairy allergy, whether the subject has a liver problem, and whether the subject is taking a medication that interacts with budesonide; 
 the first plurality of filters includes a first dairy allergy filter that is fired at least when the first plurality of survey results indicates the subject has a severe dairy allergy; 
 the second plurality of survey results includes a first liver disease filter that is fired at least when the first plurality of survey results indicates that the subject has a liver problem; and 
 the second plurality of survey results includes a first drug interaction filter that is fired at least when the first plurality of survey results indicates that the subject is taking a medication that interacts with budesonide. 
 
     
     
         16 . The computer system according to any one of  claims 1 - 14  wherein:
 the corticosteroid pharmaceutical composition comprises mometasone furoate; 
 the first plurality of survey results further indicates: whether the subject has a dairy allergy, whether the subject has a liver problem, and whether the subject is taking a medication that interacts with mometasone furoate; 
 the first plurality of filters includes a first dairy allergy filter that is fired at least when the first plurality of survey results indicates the subject has a severe dairy allergy; 
 the second plurality of survey results includes a first liver disease filter that is fired at least when the first plurality of survey results indicates that the subject has a liver problem; and 
 the second plurality of survey results includes a first drug interaction filter that is fired at least when the first plurality of survey results indicates that the subject is taking a medication that interacts with mometasone furoate. 
 
     
     
         17 . The computer system according to any one of  claims 1 - 14  wherein:
 the corticosteroid pharmaceutical composition comprises fluticasone propionate; 
 the first plurality of survey results further indicates: whether the subject has a liver problem; and 
 the second plurality of survey results includes a first liver disease filter that is fired at least when the first plurality of survey results indicates that the subject has a liver problem. 
 
     
     
         18 . The computer system according to any one of  claims 1 - 14  wherein:
 the corticosteroid pharmaceutical composition comprises beclometasone dipropionate; 
 the first plurality of survey results further indicates: whether the subject has a dairy allergy, whether the subject has a liver problem, and whether the subject is taking a medication that interacts with beclometasone dipropionate; 
 the first plurality of filters includes a first dairy allergy filter that is fired at least when the first plurality of survey results indicates the subject has a severe dairy allergy; 
 the second plurality of survey results includes a first liver disease filter that is fired at least when the first plurality of survey results indicates that the subject has a liver problem; and 
 the second plurality of survey results includes a first drug interaction filter that is fired at least when the first plurality of survey results indicates that the subject is taking a medication that interacts with beclometasone dipropionate. 
 
     
     
         19 . The computer system according to any one of  claims 15 ,  16 , and  18 , wherein the first drug interaction filter is fired when the first plurality of survey results indicates that the subject is taking a medication selected from the group consisting of a corticosteroid medicine, an anticonvulsant, an immunosuppressant, ketoconazole, a medicine for the liver, and a prescription anti-retroviral. 
     
     
         20 . The computer system according to any one of  claims 1 - 19 , wherein:
 the first plurality of survey results further comprises whether the subject is allergic to the corticosteroid pharmaceutical composition, and   the first plurality of filters includes an adverse reaction filter that is fired when the first plurality of survey results indicates that the subject is allergic to the corticosteroid pharmaceutical composition.   
     
     
         21 . The computer system according to any one of  claims 1 - 20 , wherein:
 the warning corresponding to a respective filter in the second plurality of filters comprises a prompt for the user to indicate whether they have discussed the risk factor underlying the respective filter in the second plurality of filters that was fired with a health care provider; and   acknowledgement is obtained from the subject when the subject indicates that they have discussed the risk factor underlying the respective filter in the second plurality of filters that was fired with a health care provider.   
     
     
         22 . The computer system according to any one of  claims 1 - 21 , wherein the fulfillment process further comprises:
 storing a destination associated with the subject in the subject profile.   
     
     
         23 . The computer system according to any one of  claims 1 - 22 , wherein the fulfillment process further comprises:
 coordinating shipping of the corticosteroid pharmaceutical composition to a physical address associated with the subject.   
     
     
         24 . The computer system according to any one of  claims 1 - 23 , wherein the method further comprises:
 f) responsive to receiving a re-order request from the subject for the corticosteroid pharmaceutical composition, performing a re-fulfillment procedure comprising:
 (i) conducting a second survey of the subject thereby obtaining a second plurality of survey results, wherein the second plurality of survey results comprises:
 whether the subject is taking a steroid medication, 
 a pulmonary function status of the subject, 
 whether the subject has observed an improvement in the symptoms of asthma since receiving their last provision of the corticosteroid pharmaceutical composition, 
 whether the subject has or has been in contact with someone having chicken pox, measles, or tuberculosis since receiving their last provision of the corticosteroid pharmaceutical composition, 
 whether the subject has experienced symptoms of an infection since receiving their last provision of the corticosteroid pharmaceutical composition, 
 a vision deterioration status of the subject, 
 an oral health status of the subject, 
 whether the subject has developed an infection since receiving their last provision of the corticosteroid pharmaceutical composition, 
 a surgery status of the subject, 
 a bone density status of the subject, and 
 whether the subject has developed cataracts or glaucoma since receiving their last provision of the corticosteroid pharmaceutical composition; 
 
 (ii) running all or a portion of the second plurality of survey results against a third plurality of filters of the first category class, wherein, when a respective filter in the third plurality of filters is fired, the subject is deemed not qualified for the corticosteroid pharmaceutical composition and the re-fulfillment process is terminated without delivery of the corticosteroid pharmaceutical composition to the subject, wherein the third plurality of filters comprises:
 a second steroid medication filter that is fired at least when the second plurality of survey results indicates that the subject is taking a steroid medication, 
 a second pulmonary function filter that is fired at least when the second plurality of survey results indicates that the subject has compromised pulmonary function, and 
 an asthma reduction filter that is fired when the second plurality of survey results indicates that the subject has not observed an improvement in symptoms of asthma; 
 
 (iii) running all or a portion of the second plurality of survey results against a fourth plurality of filters of the second category class, wherein, when a respective filter in the fourth plurality of filters is fired, the subject is provided with a warning corresponding to the respective filter, and wherein the fourth plurality of filters comprises:
 An infectious disease contact filter that is fired at least when the second plurality of survey results indicates that the subject has or has been in contact with someone having chicken pox, measles, or tuberculosis since receiving their last provision of the corticosteroid pharmaceutical composition, 
 a symptoms of infection filter that is fired at least when the second plurality of survey results indicates that the subject has experienced symptoms of an infection, 
 a vision deterioration filter that is fired at least when the second plurality of survey results indicates that the subject has experienced a change in vision since receiving their last provision of the corticosteroid pharmaceutical composition, 
 an oral health filter that is fired at least when the second plurality of survey results indicates that the subject has experienced redness or white-colored patches in their mouth or throat since receiving their last provision of the corticosteroid pharmaceutical composition, 
 a second infection filter that is fired at least when the second plurality of survey results indicates that the subject has a severe, untreated infection, 
 a second surgery filter that is fired at least when the second plurality of survey results indicates that the subject is planning on undergoing surgery, 
 a second bone density filter that is fired at least when the second plurality of survey results indicates that the subject has decreased bone mineral density, and a second ocular disease filter that is fired at least when the second plurality of survey results indicates that the subject has developed cataracts or glaucoma since receiving their last provision of the corticosteroid pharmaceutical composition, 
 
 (iv) obtaining acknowledgment from the subject for the warning issued to the subject by any filter in the fourth plurality of filters; and 
 (v) proceeding with the re-fulfillment process when (a) the re-fulfillment process is not already terminated by the firing of a filter in the third plurality of filters and (b) the subject has acknowledged each warning associated with each filter in the fourth plurality of filters that was fired, wherein the re-fulfillment process further comprises:
 storing an indication in a subject profile of a re-order for the corticosteroid pharmaceutical composition, 
 communicating the over the counter drug facts label for the corticosteroid pharmaceutical composition to the subject, and 
 authorizing, upon confirmation from the subject that the over the counter drug facts label has been received and read, a re-order provision of the corticosteroid pharmaceutical composition to the subject. 
 
   
     
     
         25 . The computer system of  claim 24 , wherein the compromised pulmonary function, capable of firing the second pulmonary filter, is a forced expiratory volume measured over one second (FEV1) of no more than 80% of a predicted volume for the subject. 
     
     
         26 . The computer system of  claim 24  or  25 , wherein:
 the second plurality of survey results further comprises how frequently the subject experiences symptoms of asthma since receiving their last provision of the corticosteroid pharmaceutical composition, wherein a frequency with which the subject experiences symptoms of asthma, which is capable of firing the asthma reduction filter, is more than twice a week. 
 
     
     
         27 . The computer system according to any one of  claims 24 - 26 , wherein:
 the second plurality of survey results further comprises how frequently symptoms of asthma disrupt the subject's sleep since receiving their last provision of the corticosteroid pharmaceutical composition, wherein a frequency with which the subject's sleep is disrupted by symptoms of asthma, which is capable of firing the asthma reduction filter, is more than twice a month.   
     
     
         28 . The computer system according to any one of  claims 24 - 27 , wherein:
 the second plurality of survey results further comprises how frequently the subject uses a rescue inhaler since receiving their last provision of the corticosteroid pharmaceutical composition, wherein a frequency with which the subject uses a rescue inhaler, which is capable of firing the asthma reduction filter, is more than twice a week.   
     
     
         29 . The computer system according to any one of  claims 24 - 28 , wherein:
 the second plurality of survey results further comprises how frequently the subject uses oral steroids since receiving their last provision of the corticosteroid pharmaceutical composition, wherein a frequency with which the subject has used oral steroids, which is capable of firing the asthma reduction filter, is more than once in the past year.   
     
     
         30 . The computer system according to any one of  claims 24 - 29 , wherein:
 the corticosteroid pharmaceutical composition comprises budesonide;   the second plurality of survey results further indicates: whether the subject has a dairy allergy, whether the subject has developed a liver problem since receiving their last provision of budesonide, and whether the subject has begun taking a medication that interacts with budesonide since receiving their last provision of budesonide;   the third plurality of filters includes a second dairy allergy filter that is fired at least when the second plurality of survey results indicates the subject has a severe dairy allergy;   the fourth plurality of survey results includes a second liver disease filter that is fired at least when the second plurality of survey results indicates that the subject has developed a liver problem since receiving their last provision of budesonide; and   the fourth plurality of survey results includes a second drug interaction filter that is fired at least when the second plurality of survey results indicates that the subject has begun taking a medication that interacts with budesonide since receiving their last provision of budesonide.   
     
     
         31 . The computer system according to any one of  claims 24 - 29 , wherein:
 the corticosteroid pharmaceutical composition comprises mometasone furoate;   the second plurality of survey results further indicates: whether the subject has a dairy allergy, whether the subject has developed a liver problem since receiving their last provision of mometasone furoate, and whether the subject has begun taking a medication that interacts with mometasone furoate since receiving their last provision of mometasone furoate;   the third plurality of filters includes a second dairy allergy filter that is fired at least when the second plurality of survey results indicates the subject has a severe dairy allergy;   the fourth plurality of survey results includes a second liver disease filter that is fired at least when the second plurality of survey results indicates that the subject has developed a liver problem since receiving their last provision of mometasone furoate; and   the fourth plurality of survey results includes a second drug interaction filter that is fired at least when the second plurality of survey results indicates that the subject has begun taking a medication that interacts with mometasone furoate since receiving their last provision of mometasone furoate.   
     
     
         32 . The computer system according to any one of  claims 24 - 29 , wherein:
 the corticosteroid pharmaceutical composition comprises fluticasone propionate;   the second plurality of survey results further indicates: whether the subject has developed a liver problem since receiving their last provision of fluticasone propionate; and   the fourth plurality of survey results includes a second liver disease filter that is fired at least when the second plurality of survey results indicates that the subject has developed a liver problem since receiving their last provision of fluticasone propionate.   
     
     
         33 . The computer system according to any one of  claims 24 - 29 , wherein:
 the corticosteroid pharmaceutical composition comprises beclometasone dipropionate;   the second plurality of survey results further indicates: whether the subject has a dairy allergy, whether the subject has developed a liver problem since receiving their last provision of beclometasone dipropionate, and whether the subject has begun taking a medication that interacts with beclometasone dipropionate since receiving their last provision of beclometasone dipropionate;   the third plurality of filters includes a second dairy allergy filter that is fired at least when the second plurality of survey results indicates the subject has a severe dairy allergy;   the fourth plurality of survey results includes a second liver disease filter that is fired at least when the second plurality of survey results indicates that the subject has developed a liver problem since receiving their last provision of beclometasone dipropionate; and   the fourth plurality of survey results includes a second drug interaction filter that is fired at least when the second plurality of survey results indicates that the subject has begun taking a medication that interacts with beclometasone dipropionate since receiving their last provision of beclometasone dipropionate.   
     
     
         34 . The computer system according to any one of  claims 24 - 33 , wherein:
 the second plurality of survey results further comprises whether the subject has experienced a side effect from the corticosteroid pharmaceutical composition, and   the fourth plurality of filters further comprises a side effect filter that is fired at least when the second plurality of survey results indicates that the subject has experienced, since receiving their last provision of the corticosteroid pharmaceutical composition, a side effect selected from the group consisting of a sore nose, a sore throat, nausea, hay fever, an upper respiratory tract viral infection, gastroenteritis, and an ear infection.   
     
     
         35 . The computer system according to any one of  claims 24 - 34 , wherein the re-fulfillment process further comprises, when a respective filter in the third plurality of filters or fourth plurality of filters is fired, storing a record associated with the firing of the respective filter in an adverse event profile comprising records of filter firing events associated with a plurality of users. 
     
     
         36 . A method for treating or preventing symptoms of asthma in a subject in need thereof, the method comprising:
 administering a corticosteroid pharmaceutical composition to a subject qualified for over-the-counter access to the corticosteroid pharmaceutical composition.   
     
     
         37 . The method of  claim 36 , wherein the corticosteroid pharmaceutical composition comprises a class B corticosteroid. 
     
     
         38 . The method of  claim 36 , wherein the corticosteroid pharmaceutical composition comprises a glucocorticosteroid. 
     
     
         39 . The method of  claim 36 , wherein the corticosteroid pharmaceutical composition comprises 16,17-(butylidenebis(oxy))-11,21-dihydroxy-, (11-β,16-α)-pregna-1,4-diene-3,20-dione as an active ingredient. 
     
     
         40 . The method of  claim 36 , wherein the corticosteroid pharmaceutical composition includes a composition selected from the group consisting of budesonide, ciclesonide, fluticasone furoate, mometasone furoate, fluticasone propionate, and beclomethasone dipropionate. 
     
     
         41 . The method of  claim 40 , wherein the subject is administered from 90 mcg to 270 mg of budesonide, or a pharmaceutically acceptable salt thereof, twice per day. 
     
     
         42 . The method of  claim 40 , wherein the subject is administered from 40 mcg to 120 mg of ciclesonide, or a pharmaceutically acceptable salt thereof, twice per day. 
     
     
         43 . The method of  claim 40 , wherein the subject is administered from 50 mcg to 150 mg of fluticasone furoate, or a pharmaceutically acceptable salt thereof, per day. 
     
     
         44 . The method of  claim 40 , wherein the subject is administered from 50 mcg to 150 mg of mometasone furoate, or a pharmaceutically acceptable salt thereof, per day. 
     
     
         45 . The method of  claim 40 , wherein the subject is administered from 44 mcg to 110 mg of fluticasone propionate, or a pharmaceutically acceptable salt thereof, twice per day. 
     
     
         46 . The method of  claim 40 , wherein the subject is administered from 40 mcg to 120 mg of beclomethasone dipropionate, or a pharmaceutically acceptable salt thereof, twice per day.