A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma

NCT00139659

Last updated date
Study Location
Pfizer Investigational Site
Glendale, Arizona, 85306, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma, Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-77 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin

- Mild intermittent or mild to moderate persistent asthma

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking

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Asthma, Diabetes MellitusA One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
NCT00139659
  1. Glendale, Arizona
  2. Peoria, Arizona
  3. Phoenix, Arizona
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Tucson, Arizona
  7. Jonesboro, Arkansas
  8. Searcy, Arkansas
  9. Berkeley, California
  10. Beverly Hills, California
  11. Fresno, California
  12. Greenbrae, California
  13. Huntington Beach, California
  14. Los Angeles, California
  15. Riverside, California
  16. San Diego, California
  17. San Diego, California
  18. Tustin, California
  19. Boulder, Colorado
  20. Denver, Colorado
  21. Denver, Colorado
  22. Denver, Colorado
  23. Waterbury, Connecticut
  24. Newark, Delaware
  25. Chiefland, Florida
  26. Clearwater, Florida
  27. Clearwater, Florida
  28. Melbourne, Florida
  29. Miami, Florida
  30. West Palm Beach, Florida
  31. West Palm Beach, Florida
  32. Augusta, Georgia
  33. Honolulu, Hawaii
  34. Honululu, Hawaii
  35. Chicago, Illinois
  36. Normal, Illinois
  37. Evansville, Indiana
  38. Indianapolis, Indiana
  39. Des Moines, Iowa
  40. Dubuque, Iowa
  41. Dubuque, Iowa
  42. Wichita, Kansas
  43. Bossier City, Louisiana
  44. North Dartmouth, Massachusetts
  45. Springfield, Massachusetts
  46. Springfield, Massachusetts
  47. Waltham, Massachusetts
  48. Brooklyn Center, Minnesota
  49. St. Louis, Missouri
  50. Butte, Montana
  51. Henderson, Nevada
  52. Las Vegas, Nevada
  53. Las Vegas, Nevada
  54. North Las Vegas, Nevada
  55. Albuquerque, New Mexico
  56. Buffalo, New York
  57. New York, New York
  58. Cincinnati, Ohio
  59. Cincinnati, Ohio
  60. Cincinnati, Ohio
  61. Dayton, Ohio
  62. Toledo, Ohio
  63. Toledo, Ohio
  64. Oklahoma City, Oklahoma
  65. Medford, Oregon
  66. Portland, Oregon
  67. Portland, Oregon
  68. Lansdale, Pennsylvania
  69. Pittsburgh, Pennsylvania
  70. Spartanburg, South Carolina
  71. Spartanburg, South Carolina
  72. Bartlett, Tennessee
  73. Memphis, Tennessee
  74. Nashville, Tennessee
  75. Beaumont, Texas
  76. Dallas, Texas
  77. Houstan, Texas
  78. Houston, Texas
  79. Houston, Texas
  80. San Antonio, Texas
  81. San Antonio, Texas
  82. Norfolk, Virginia
  83. Richmond, Virginia
  84. Richmond, Virginia
  85. Spokane, Washington
  86. Spokane, Washington
  87. Porto Alegre, RS
  88. SP, Sao Paulo
  89. Campinas, SP
  90. Sao Paulo, SP
  91. Edmonton, Alberta
  92. Red Deer, Alberta
  93. Victoria, British Columbia
  94. Winnipeg, Manitoba
  95. Winnipeg, Manitoba
  96. Burlington, Ontario
  97. London, Ontario
  98. Laval, Quebec
  99. Montreal, Quebec
  100. Sherbrooke, Quebec
  101. San Jose,
  102. Neuss,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma
Official Title  ICMJE Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Asthma: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial
Brief Summary A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Diabetes Mellitus
Intervention  ICMJE
  • Drug: Inhaled Insulin
    Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine.
  • Drug: Subcutaneous Insulin
    Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.
Study Arms  ICMJE
  • Experimental: Inhaled Insulin
    Intervention: Drug: Inhaled Insulin
  • Active Comparator: Subcutaneous Insulin
    Intervention: Drug: Subcutaneous Insulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2010)
288
Original Enrollment  ICMJE
 (submitted: August 29, 2005)
250
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
  • Mild intermittent or mild to moderate persistent asthma

Exclusion Criteria:

  • Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Canada,   Costa Rica,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00139659
Other Study ID Numbers  ICMJE A2171028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP