Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma

Back to Search
Print
Bookmark Trial

NCT00425061

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Alabama Allergy and Asthma Center
Birmingham, Alabama, 35209, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.

- History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.

- FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

AsthmaEvaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma I
NCT01172808
  1. Huntington Beach, California
  2. Mission Viejo, California
  3. San Diego, California
  4. Wheat Ridge, Colorado
  5. Coeur d'Alene, Idaho
  6. Normal, Illinois
  7. South Bend, Indiana
  8. Baltimore, Maryland
  9. North Dartmouth, Massachusetts
  10. North Dartmouth, Massachusetts
  11. Minneapolis, Minnesota
  12. Bellevue, Nebraska
  13. Boys Town, Nebraska
  14. Omaha, Nebraska
  15. Winston-Salem, North Carolina
  16. Oklahoma City, Oklahoma
  17. Charleston, South Carolina
  18. Easely, South Carolina
  19. Dallas, Texas
  20. Seattle, Washington
  21. Tacoma, Washington
  22. Juiz de Fora,
  23. Porto Alegre,
  24. Porto Alegre,
  25. Porto Alegre,
  26. Rio de Janeiro - RJ,
  27. Beijing,
  28. Beijing,
  29. Beijing,
  30. Beijing,
  31. Changsha,
  32. Chengdu,
  33. Chengdu,
  34. Chongqing,
  35. Guangzhou,
  36. Kunming,
  37. Qingdao,
  38. Shanghai,
  39. Shenyang,
  40. Shenyang,
  41. Xi'An,
  42. Guatelama City,
  43. Guatelmala city,
  44. Guatelmala City,
  45. Guatemala City,
  46. Guatemala city,
  47. Banglore,
  48. Chennai,
  49. Coimbatore,
  50. Coimbatore,
  51. Hyderabad,
  52. Jaipur,
  53. Nagpur,
  54. Pune,
  55. Pune,
  56. Adachi-ku, Tokyo,
  57. Ako, Hyogo,
  58. Chiyoda-ku, Tokyo,
  59. Chuo-ku, Tokyo,
  60. Chuo-ku, Tokyo,
  61. Fujioka, Gunma,
  62. Himeji, Hyogo,
  63. Hitachi, Ibaraki,
  64. Iwamizawa, Hokkaido,
  65. Kanazawa, Ishikawa,
  66. Kitakami, Iwate,
  67. Kitakami, Iwate,
  68. Koga, Ibaraki,
  69. Koganei, Tokyo,
  70. Komaki, Aichi,
  71. Kunitachi, Tokyo,
  72. Mito, Ibaraki,
  73. Osaka, Osaka,
  74. Ota-ku, Tokyo,
  75. Sapporo, Hokkaido,
  76. Sendai, Miyagi,
  77. Sendai, Miyagi,
  78. Setagaya-ku, Tokyo,
  79. Takasaki, Gunma,
  80. Tomakomai, Hokkaido,
  81. Toshima-ku, Tokyo,
  82. Toshima-ku, Tokyo,
  83. Yao, Osaka,
  84. Yokohama, Kanagawa,
  85. Yokohama, Kanagawa,
  86. Daugavpils,
  87. Preili,
  88. Riga,
  89. Riga,
  90. Riga,
  91. Riga,
  92. Riga,
  93. Riga,
  94. Ventspils,
  95. Monterrey,
  96. Zapopan,
  97. Zona Río,
  98. Callao,
  99. Lima,
  100. Lima,
  101. Krakow,
  102. Lodz,
  103. Lodz,
  104. Ostrow Wielkopolska,
  105. Poznan,
  106. Tczew,
  107. Gatchina (Leningradskaya oblast),
  108. Moscow,
  109. Moscow,
  110. Moscow,
  111. Moscow,
  112. St. Petersburg,
  113. St. Petersburg,
  114. St. Petersburg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
AsthmaEvaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II
NCT01172821
  1. Los Angeles, California
  2. Stockton, California
  3. Centennial, Colorado
  4. Denver, Colorado
  5. Panama City, Florida
  6. Winter Park, Florida
  7. Novi, Michigan
  8. Plymouth, Minnesota
  9. St. Louis, Missouri
  10. Bozeman, Montana
  11. Skillman, New Jersey
  12. Raleigh, North Carolina
  13. Cincinnati, Ohio
  14. Portland, Oregon
  15. Greenville, South Carolina
  16. Union, South Carolina
  17. El Paso, Texas
  18. San Antonio, Texas
  19. Florianopolis,
  20. Porto Alegre,
  21. Sao Paulo,
  22. Sao Paulo,
  23. Chengdu,
  24. Chongqing,
  25. Guangzhou,
  26. Guangzhou,
  27. Haikou,
  28. Kunming,
  29. Nanchang,
  30. Nanjing,
  31. Shanghai,
  32. Shanghai,
  33. Shanghai,
  34. Shanghai,
  35. Xi'An,
  36. Xi'An,
  37. Xuzhou,
  38. Yangzhou,
  39. Yinchuan,
  40. Bogota,
  41. Bogota,
  42. Bogota,
  43. Medelin,
  44. Bamberg,
  45. Berlin,
  46. Berlin,
  47. Berlin,
  48. Berlin,
  49. Berlin,
  50. Frankfurt,
  51. Hamburg,
  52. Koblenz,
  53. Lübeck,
  54. Rüdersdorf,
  55. Wiesbaden,
  56. Witten,
  57. Ahmedabad,
  58. Coimbatore,
  59. Hyderabad,
  60. Jaipur,
  61. Jaipur,
  62. Mumbai,
  63. Mysore,
  64. Nagpur,
  65. Aira, Kagoshima,
  66. Chuo-ku, Tokyo,
  67. Fukuoka, Fukuoka,
  68. Fukuoka, Fukuoka,
  69. Fukuyama, Hiroshima,
  70. Habikino, Osaka,
  71. Hiroshima, Hiroshima,
  72. Itabashi-ku, Tokyo,
  73. Iwata, Shizuoka,
  74. Kanazawa, Ishikawa,
  75. Kishiwada, Osaka,
  76. Kitakyushu, Fukuoka,
  77. Kobe, Hyogo,
  78. Koto-ku, Tokyo,
  79. Kyoto, Kyoto,
  80. Matsusaka, Mie,
  81. Meguro-ku, Tokyo,
  82. Minato-ku, Tokyo,
  83. Minato-ku, Tokyo,
  84. Morioka, Iwate,
  85. Naka-gun, Ibaraki,
  86. Nakano-ku,Tokyo,
  87. Oita,Oita,
  88. Osaka-Sayama, Osaka,
  89. Sapporo, Hokkaido,
  90. Sendai, Miyagi,
  91. Seto, Aichi,
  92. Shinagawa-ku, Tokyo,
  93. Shizuoka, Shizuoka,
  94. Toyota, Aichi,
  95. Urasoe, Okinawa,
  96. Urasoe, Okinawa,
  97. Urasoe, Okinawa,
  98. Yokohama, Kanagawa,
  99. Yotsukaido, Chiba,
  100. Mexico City,
  101. Mexico City,
  102. Monterrey,
  103. Lima,
  104. Lima,
  105. Lima,
  106. Lima,
  107. Lima,
  108. Bialystok,
  109. Bydgoszcz,
  110. Gorzow Wielkopolski,
  111. Krakow,
  112. Poznan,
  113. Sopot,
  114. Wloszczowa,
  115. Wroclaw,
  116. Brasov,
  117. Brasov,
  118. Bucharest,
  119. Bucharest,
  120. Bucharest,
  121. Bucharest,
  122. Bucharest,
  123. Bucuresti,
  124. Constanta,
  125. Iasi,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
AsthmaEfficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
NCT01122680
  1. Denver, Colorado
  2. Columbia, Missouri
  3. Warrensburg, Missouri
  4. Boys Town, Nebraska
  5. Canton, Ohio
  6. Koblenz,
  7. Rosenheim,
  8. Wesel,
  9. Balvi,
  10. Daugavpils,
  11. Rezekne,
  12. Riga,
  13. Riga,
  14. Vilnius,
  15. Vilnius,
  16. Vilnius,
  17. Kamnik,
  18. Ljubljana,
  19. Maribor,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
AsthmaRandomised, Double- Blind, Cross-over Efficacy and Safety Comparison of Three Different Doses of Tiotropium Administered Once Daily Versus Placebo in Patients With Moderate Persistent Asthma.
NCT01233284
  1. Hallein,
  2. Linz,
  3. Neumarkt am Wallersee,
  4. Schlüsslberg,
  5. Thalheim bei Wels,
  6. Berlin,
  7. Berlin,
  8. Frankfurt,
  9. Hamburg,
  10. Hannover,
  11. Mainz,
  12. Schwerin,
  13. Wiesbaden,
  14. Wiesloch,
  15. Ivano-Frankivsk,
  16. Kharkiv,
  17. Kharkiv,
  18. Kiev,
  19. Kiev,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Effect of IMA-638 in Subjects With Persistent Asthma
Official Title  ICMJE Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study Conducted Sequentially With 3 Doses Of Ima-638 Administered Sc.
Brief Summary Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Biological: IMA-638
    SC Injection, 12 weeks
  • Other: placebo
    placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: IMA-638
  • Experimental: 2
    Intervention: Biological: IMA-638
  • Placebo Comparator: 3
    Intervention: Other: placebo
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 11, 2014)		159
Original Enrollment  ICMJE
 (submitted: January 19, 2007)		120
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.
  • History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.
  • FEV1 ? 55% to ? 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ? 12%.

Exclusion Criteria:

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00425061
Other Study ID Numbers  ICMJE 3174K1-201
B2421007 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2015

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