This study is to evaluate the efficacy and safety of an oral investigational drug in patients with stable asthma. Patient will be withdrawn from their current controller medication and enter a run-in phase. Throughout the study patients will have supplies of rescue medication (inhaled albuterol/salbutamol). After completion of the run-in phase, patients will be re-evaluated and those who meet all entry criteria will be randomized at a 1:1:1 ratio to receive either, the investigational drug at 250 mcg, 500 mcg or placebo daily. During the 24-week double-blind treatment period patients will be evaluated in the morning at the investigator’s clinic at weeks 2, 4, 8, 12, 18, and 24. At each clinic visit, patients will complete relevant questionnaires, undergo spirometry, review of electronic diaries, and complete laboratory procedures.

Condition	Treatment or Intervention	Phase
Asthma	Drug: Investigational New Drug	Phase III

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Men and women aged 18 through 70 years of age
• The patient has received verbal and written study information
• The patient has a diagnosis of persistent bronchial asthma
• There has been no change in asthma treatment within 4 weeks prior to Visit 1
• Patient is a non-smoker or ex-smoker (for 12 months or longer)
• In the investigators judgment, the patient is able and willing to complete study activities

Exclusion Criteria:

• Patients with poorly controlled asthma or those that suffer from seasonal asthma alone
• A history of lower airway infection
• A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
• Abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
• A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to Visit 1
• Patients with chronic heart failure
• Suspected hypersensitivity and/or contraindication to the study medication or albuterol/salbutamol
• Females who are pregnant or breast-feeding
• Patients who have received any investigational medication or device in the month prior to Visit 1 or who plan to use another investigational medication during the study
• Patients who have any other severe medical or psychiatric conditions in the judgment of the investigator, would make the patient inappropriate for entry into this study
• Spirometry results outside of the limits set by the study

Call:      1-734-622-7600    ClinicalTrials.gov@Pfizer.com

Alabama
      Pfizer Investigational Site, Jasper,  Alabama,  35501,  United States; Recruiting
Arizona
      Pfizer Investigational Site, Phoenix,  Arizona,  85016,  United States; Recruiting
      Pfizer Investigational Site, Tucson,  Arizona,  85712,  United States; Terminated
California
      Pfizer Investigational Site, Anaheim,  California,  92805,  United States; Recruiting
      Pfizer Investigational Site, Anaheim,  California,  92804,  United States; Recruiting
      Pfizer Investigational Site, Carmichael,  California,  95608,  United States; Terminated
      Pfizer Investigational Site, Hawaiian Gardens,  California,  90716,  United States; Terminated
      Pfizer Investigational Site, Long Beach,  California,  90808,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90025,  United States; Recruiting
      Pfizer Investigational Site, San Diego,  California,  92120,  United States; Recruiting
      Pfizer Investigational Site, Fountain Valley,  California,  92708,  United States; Recruiting
      Pfizer Investigational Site, San Diego,  California,  92123,  United States; Terminated
      Pfizer Investigational Site, Rancho Mirage,  California,  92210,  United States; Recruiting
      Pfizer Investigational Site, Rolling Hills Estates,  California,  90274,  United States; Terminated
      Pfizer Investigational Site, San Diego,  California,  92131,  United States; Recruiting
      Pfizer Investigational Site, Carmichael,  California,  95608,  United States; Recruiting
      Pfizer Investigational Site, Anaheim,  California,  92804,  United States; Terminated
      Pfizer Investigational Site, Carmichael,  California,  95608,  United States; Recruiting
      Pfizer Investigational Site, Huntington Beach,  California,  92647,  United States; Recruiting
Colorado
      Pfizer Investigational Site, Englewood,  Colorado,  80112,  United States; Terminated
      Pfizer Investigational Site, Lakewood,  Colorado,  80401,  United States; Recruiting
      Pfizer Investigational Site, Wheat Ridge,  Colorado,  80033,  United States; Recruiting
      Pfizer Investigational Site, Denver,  Colorado,  80209,  United States; Terminated
Florida
      Pfizer Investigational Site, Altamonte Springs,  Florida,  32701,  United States; Recruiting
      Pfizer Investigational Site, Coral Gables,  Florida,  33134,  United States; Recruiting
      Pfizer Investigational Site, Merritt Island,  Florida,  32953,  United States; Terminated
      Pfizer Investigational Site, Gainesville,  Florida,  32605,  United States; Recruiting
      Pfizer Investigational Site, Longwood,  Florida,  32750,  United States; Terminated
      Pfizer Investigational Site, St. Petersburg,  Florida,  33703,  United States; Recruiting
      Pfizer Investigational Site, St. Petersburg,  Florida,  33710,  United States; Terminated
Georgia
      Pfizer Investigational Site, Athens,  Georgia,  30606,  United States; Recruiting
      Pfizer Investigational Site, Atlanta,  Georgia,  30342,  United States; No longer recruiting
      Pfizer Investigational Site, Savannah,  Georgia,  31406,  United States; Recruiting
      Pfizer Investigational Site, Stockbridge,  Georgia,  30281,  United States; Recruiting
      Pfizer Investigational Site, Decatur,  Georgia,  30023,  United States; No longer recruiting
      Pfizer Investigational Site, Augusta,  Georgia,  30901,  United States; Terminated
      Pfizer Investigational Site, Gainesville,  Georgia,  30501,  United States; Recruiting
      Pfizer Investigational Site, Atlanta,  Georgia,  30309,  United States; Recruiting
Idaho
      Pfizer Investigational Site, Coeur D Alene,  Idaho,  83814,  United States; Terminated
      Pfizer Investigational Site, Twin Falls,  Idaho,  83301,  United States; Recruiting
Illinois
      Pfizer Investigational Site, Chicago,  Illinois,  United States; Recruiting
      Pfizer Investigational Site, Peoria,  Illinois,  61602,  United States; Terminated
      Pfizer Investigational Site, Chicago,  Illinois,  United States; Recruiting
Indiana
      Pfizer Investigational Site, South Bend,  Indiana,  United States; Recruiting
Iowa
      Pfizer Investigational Site, Dubuque,  Iowa,  52001,  United States; Recruiting
      Pfizer Investigational Site, Des Moines,  Iowa,  50315,  United States; Recruiting
Kansas
      Pfizer Investigational Site, Overland Park,  Kansas,  66210,  United States; Recruiting
      Pfizer Investigational Site, Shawnee Mission,  Kansas,  66216,  United States; Terminated
      Pfizer Investigational Site, Olathe,  Kansas,  66061,  United States; Terminated
Kentucky
      Pfizer Investigational Site, Louisville,  Kentucky,  40222,  United States; Recruiting
Louisiana
      Pfizer Investigational Site, Kenner,  Louisiana,  70062,  United States; Recruiting
      Pfizer Investigational Site, Metairie,  Louisiana,  70005,  United States; Recruiting
Maryland
      Pfizer Investigational Site, Wharton,  Maryland,  20902,  United States; Recruiting
      Pfizer Investigational Site, Chester,  Maryland,  21619,  United States; Recruiting
Massachusetts
      Pfizer Investigational Site, North Dartmouth,  Massachusetts,  02747,  United States; Recruiting
Michigan
      Pfizer Investigational Site, Ann Arbor,  Michigan,  48106,  United States; Recruiting
      Pfizer Investigational Site, Cadillac,  Michigan,  49601,  United States; Terminated
      Pfizer Investigational Site, Kalamazoo,  Michigan,  49008,  United States; Recruiting
      Pfizer Investigational Site, Traverse City,  Michigan,  49684,  United States; Terminated
      Pfizer Investigational Site, Ann Arbor,  Michigan,  48106,  United States; Recruiting
      Pfizer Investigational Site, Royal Oak,  Michigan,  48073,  United States; Recruiting
      Pfizer Investigational Site, Bridgeman,  Michigan,  49106,  United States; Terminated
Minnesota
      Pfizer Investigational Site, Minneapolis,  Minnesota,  55416,  United States; Recruiting
Mississippi
      Pfizer Investigational Site, Jackson,  Mississippi,  39202,  United States; Recruiting
Missouri
      Pfizer Investigational Site, Columbia,  Missouri,  65203,  United States; Recruiting
      Pfizer Investigational Site, St. Louis,  Missouri,  63141,  United States; Recruiting
      Pfizer Investigational Site, Independence,  Missouri,  64055,  United States; Recruiting
      Pfizer Investigational Site, St. Louis,  Missouri,  63141,  United States; Recruiting
      Pfizer Investigational Site, Jefferson City,  Missouri,  65109,  United States; Recruiting
Montana
      Pfizer Investigational Site, Bozeman,  Montana,  59718,  United States; Recruiting
Nebraska
      Pfizer Investigational Site, Lincoln,  Nebraska,  68505,  United States; Recruiting
Nevada
      Pfizer Investigational Site, Henderson,  Nevada,  89014,  United States; Recruiting
New Jersey
      Pfizer Investigational Site, Margate,  New Jersey,  08402,  United States; Recruiting
      Pfizer Investigational Site, Teaneck,  New Jersey,  07666,  United States; Recruiting
New York
      Pfizer Investigational Site, Johnson City,  New York,  13790,  United States; Recruiting
      Pfizer Investigational Site, Rochester,  New York,  14618,  United States; Recruiting
      Pfizer Investigational Site, New York,  New York,  11021,  United States; Recruiting
      Pfizer Investigational Site, Bronx,  New York,  10467,  United States; Recruiting
      Pfizer Investigational Site, Huntington Station,  New York,  11746,  United States; Recruiting
      Pfizer Investigational Site, Johnson City,  New York,  13790,  United States; Recruiting
      Pfizer Investigational Site, Bay Shore,  New York,  11706,  United States; Recruiting
North Carolina
      Pfizer Investigational Site, Charleston,  North Carolina,  29407,  United States; Terminated
      Pfizer Investigational Site, Raleigh,  North Carolina,  27612,  United States; Terminated
      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Pfizer Investigational Site, Charlotte,  North Carolina,  28209,  United States; Recruiting
      Pfizer Investigational Site, Charlotte,  North Carolina,  28207,  United States; Terminated
      Pfizer Investigational Site, Salisbury,  North Carolina,  28144,  United States; Recruiting
      Pfizer Investigational Site, Charlotte,  North Carolina,  28262,  United States; Recruiting
      Pfizer Investigational Site, High Point,  North Carolina,  27262,  United States; Recruiting
North Dakota
      Pfizer Investigational Site, Fargo,  North Dakota,  58103,  United States; Recruiting
      Pfizer Investigational Site, Jamestown,  North Dakota,  58401,  United States; Terminated
      Pfizer Investigational Site, Jamestown,  North Dakota,  58401,  United States; Terminated
Oregon
      Pfizer Investigational Site, Medford,  Oregon,  97504,  United States; Recruiting
      Pfizer Investigational Site, Portland,  Oregon,  97213,  United States; Recruiting
Pennsylvania
      Pfizer Investigational Site, Dresner,  Pennsylvania,  19025,  United States; Recruiting
      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19115,  United States; Recruiting
      Pfizer Investigational Site, Pittsburgh,  Pennsylvania,  15218,  United States; Terminated
      Pfizer Investigational Site, Conshohocken,  Pennsylvania,  19428,  United States; Terminated
Rhode Island
      Pfizer Investigational Site, Providence,  Rhode Island,  02906,  United States; Recruiting
      Pfizer Investigational Site, Lincoln,  Rhode Island,  02865,  United States; Recruiting
      Pfizer Investigational Site, East Providence,  Rhode Island,  02914,  United States; Recruiting
South Carolina
      Pfizer Investigational Site, Spartanburg,  South Carolina,  29307,  United States; Recruiting
Tennessee
      Pfizer Investigational Site, Knoxville,  Tennessee,  37922,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37203,  United States; Recruiting
Texas
      Pfizer Investigational Site, Austin,  Texas,  78746,  United States; Terminated
      Pfizer Investigational Site, Denton,  Texas,  76201,  United States; Recruiting
      Pfizer Investigational Site, Houston,  Texas,  77054,  United States; Recruiting
      Pfizer Investigational Site, San Angelo,  Texas,  United States; Terminated
      Pfizer Investigational Site, San Antonio,  Texas,  78229,  United States; Recruiting
      Pfizer Investigational Site, Austin,  Texas,  78728,  United States; Recruiting
      Pfizer Investigational Site, San Antonio,  Texas,  78207,  United States; Recruiting
      Pfizer Investigational Site, Austin,  Texas,  78750,  United States; Recruiting
      Pfizer Investigational Site, Dallas,  Texas,  75231,  United States; Recruiting
Utah
      Pfizer Investigational Site, Murray,  Utah,  84107,  United States; Recruiting
Virginia
      Pfizer Investigational Site, Arlington,  Virginia,  22203,  United States; Recruiting
      Pfizer Investigational Site, Charlottesville,  Virginia,  22911,  United States; Recruiting
Washington
      Pfizer Investigational Site, Kirkland,  Washington,  98034,  United States; Recruiting
      Pfizer Investigational Site, Spokane,  Washington,  99202,  United States; Recruiting
Wisconsin
      Pfizer Investigational Site, Madison,  Wisconsin,  53792,  United States; Recruiting
      Pfizer Investigational Site, Greenfield,  Wisconsin,  53228,  United States; Recruiting
Argentina
      Pfizer Investigational Site, Capital Federal,  C1425DTG,  Argentina; Recruiting
      Pfizer Investigational Site, Capital Federal,  1272,  Argentina; Recruiting
Argentina, Buenos Aires
      Pfizer Investigational Site, Lanus,  Buenos Aires,  B1824DRL,  Argentina; Recruiting
      Pfizer Investigational Site, Capital Federal,  Buenos Aires,  Argentina; Recruiting
      Pfizer Investigational Site, Capital Federal,  Buenos Aires,  1120,  Argentina; Recruiting
      Pfizer Investigational Site, La Plata,  Buenos Aires,  1900,  Argentina; Recruiting
      Pfizer Investigational Site, Vicente Lopez,  Buenos Aires,  1602,  Argentina; Recruiting
      Pfizer Investigational Site, Capital Federal,  Buenos Aires,  1120,  Argentina; Recruiting
      Pfizer Investigational Site, Capital Federal,  Buenos Aires,  1427,  Argentina; Recruiting
Argentina, Santa Fe
      Pfizer Investigational Site, Rosario,  Santa Fe,  2000,  Argentina; Recruiting
Colombia, Cundinamarca
      Pfizer Investigational Site, Bogota,  Cundinamarca,  000,  Colombia; Recruiting
      Pfizer Investigational Site, Bogota,  Cundinamarca,  000,  Colombia; Recruiting
Colombia, Santander
      Pfizer Investigational Site, Bucaramanga,  Santander,  000,  Colombia; Recruiting
Mexico
      Pfizer Investigational Site, Monterrey,  Mexico; Terminated
      Pfizer Investigational Site, Guadalajara,  Mexico; Recruiting
      Pfizer Investigational Site, Mexico City,  Mexico; Recruiting
      Pfizer Investigational Site, Mexico City,  14080,  Mexico; Recruiting
      Pfizer Investigational Site, Guadalajara,  Mexico; Recruiting
Mexico, Jalisco
      Pfizer Investigational Site, Guadalajara,  Jalisco,  41130,  Mexico; Not yet recruiting
Mexico, Nuevo Leon
      Pfizer Investigational Site, Monterrey,  Nuevo Leon,  Mexico; Recruiting
Peru
      Pfizer Investigational Site, Lima,  27,  Peru; Recruiting
      Pfizer Investigational Site, Lima,  27,  Peru; Recruiting
      Pfizer Investigational Site, Lima,  32,  Peru; Recruiting
      Pfizer Investigational Site, Lima,  27,  Peru; Recruiting

Study ID Numbers:  PDEAAS-1500-002
Record last reviewed:  October 2004
Record first received:  November 17, 2003
ClinicalTrials.gov Identifier:  NCT00073177
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-22