Phase4/Symbicort Versus Pulmicort Flexhaler in African Americans

Condition(s) targeted: Asthma

Intervention: Budesonide /formoterol fumarate (Drug); Budesonide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Ubaldo Martin, MD, Study Director, Affiliation: AstraZeneca
Tomas LG Andersson, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

To compare the efficacy of SYMBICORT® pMDI 160/4. 5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.

Official title: A 12-wk, Rand., Double-Blind, Double Dummy, Multi-Ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: change from baseline in the pre-dose forced expiratory volume in one second (FEV1) averaged over the double-blind treatment period

Secondary outcome:

AM Peak Expiratory Flow (PEF)

PM Peak Expiratory Flow (PEF)

Spirometry Measures [forced vital capacity (FVC), forced expiratory flow (FEF)]

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- African American (self-reported

- Documented clinical diagnosis of asthma as defined by the American Thoracic Society

(ATS) for at least 6 months prior to Visit 2 and be in stable condition.

- FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48

hours after LABA, of 45%-85%, inclusive, of predicted normal.

Exclusion Criteria:

- Has been hospitalized at least once for an asthma related condition during the 6

months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.

- Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or

rectal) for any reason within the 30 days prior to Visit 2.

- Has a respiratory infection or other viral/bacterial illness, or is recovering from

such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry

AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

Research Site, Pell City, Alabama, United States; Recruiting

Research Site, Little Rock, Arkansas, United States; Recruiting

Research Site, Bentonville, Arkansas, United States; Recruiting

Research Site, Malvern, Arkansas, United States; Recruiting

Research Site, Hot Springs, Arkansas, United States; Recruiting

Research Site, Orange, California, United States; Recruiting

Research Site, Long Beach, California, United States; Recruiting

Research Site, Huntington Park, California, United States; Recruiting

Research Site, Rolling Hills Estates, California, United States; Recruiting

Research Site, Los Angles, California, United States; Recruiting

Research Site, Los Angeles, California, United States; Recruiting

Research Site, Colorado Springs, Colorado, United States; Recruiting

Research Site, Centennial, Colorado, United States; Recruiting

Research Site, Waterbury, Connecticut, United States; Recruiting

Research Site, Inverness, Florida, United States; Recruiting

Research Site, Ocala, Florida, United States; Recruiting

Research Site, Miami, Florida, United States; Recruiting

Research Site, Tampa, Florida, United States; Recruiting

Research Site, Tallahassee, Florida, United States; Recruiting

Research Site, Decatur, Georgia, United States; Recruiting

Research Site, Lovejoy, Georgia, United States; Recruiting

Research Site, Lithia Springs, Georgia, United States; Recruiting

Research Site, Alpharetta, Georgia, United States; Recruiting

Research Site, Atlanta, Georgia, United States; Recruiting

Research Site, Lawrenceville, Georgia, United States; Recruiting

Research Site, Chicago, Illinois, United States; Recruiting

Research Site, Hagerstown, Maryland, United States; Recruiting

Research Site, Largo, Maryland, United States; Recruiting

Research Site, Lanham, Maryland, United States; Recruiting

Research Site, Towson, Maryland, United States; Recruiting

Research Site, Flint, Michigan, United States; Recruiting

Research Site, Kansas City, Missouri, United States; Recruiting

Research Site, St. Louis, Missouri, United States; Recruiting

Research Site, Las Vegas, Nevada, United States; Recruiting

Research Site, Skillman, New Jersey, United States; Recruiting

Research Site, New York, New York, United States; Recruiting

Research Site, North Syracuse, New York, United States; Recruiting

Research Site, Greenville, North Carolina, United States; Recruiting

Research Site, Raleigh, North Carolina, United States; Recruiting

Research Site, Durham, North Carolina, United States; Recruiting

Research Site, Portland, Oregon, United States; Recruiting

Research Site, Blue Bell, Pennsylvania, United States; Recruiting

Research Site, Charleston, South Carolina, United States; Recruiting

Research Site, Spartanburg, South Carolina, United States; Recruiting

Research Site, Memphis, Tennessee, United States; Recruiting

Research Site, Waco, Texas, United States; Recruiting

Research Site, San Antonio, Texas, United States; Recruiting

Research Site, Dallas, Texas, United States; Recruiting

Research Site, Plano, Texas, United States; Recruiting

Research Site, Ft. Worth, Texas, United States; Recruiting

Research Site, Arlington, Texas, United States; Recruiting

Research Site, Houston, Texas, United States; Recruiting

Research Site, McKinney, Texas, United States; Recruiting

Research Site, Fort Worth, Texas, United States; Recruiting

Research Site, Emporia, Virginia, United States; Recruiting

Research Site, Virginia Beach, Virginia, United States; Recruiting

Research Site, Richmond, Virginia, United States; Recruiting

Research Site, Milwaukee, Wisconsin, United States; Recruiting

Starting date: June 2008
Ending date: October 2009
Last updated: June 27, 2008