Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans (Titan)

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Drug: Budesonide / formoterol fumarate (SYMBICORT)

Drug: Budesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00702325

D589BL00003

Details and patient eligibility

About

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.

Enrollment

311 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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