An Efficacy Study Comparing SYMBICORT® pMDI With Budesonide HFA pMDI, in Hispanic Subjects With ICS Dependent Asthma

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol (SYMBICORT) pMDI (Drug); Budesonide HFA pMDI (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christer Hultquist, MD, Study Director, Affiliation: AstraZeneca

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the Hispanic population.

Official title: A 12-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

To compare the efficacy of SYMBICORT pMDI 160/4.5 mg x 2 actuations bid to that of budesonide HFA pMDI 160 mg x 2 actuations bid, in Hispanic subjects with ICS dependent asthma.

The primary efficacy variable will be morning Peak Expiratory Flow (AM PEF)

Secondary outcome:

To evaluate the safety of SYMBICORT pMDI compared to budesonide.

To collect a peripheral blood sample for pharmacogenetic testing in consenting subjects for future pharmacogenetic analyses to be conducted outside the scope of the clinical study report

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

Criteria:

Inclusion Criteria:

- Male or Female, Hispanic (self-reported), > 12 years of age

- Moderate to severe asthma requiring treatment with an inhaled corticosteroid

- Diagnosis of asthma for at least 6 months

Exclusion Criteria:

- Subjects requiring treatment with systemic corticosteroids (e. g., oral, parenteral,

ocular)

- Any significant disease or disorder that may jeopardize a subject's safety

Research Site, Aguas Buenas, Puerto Rico

Research Site, Caquas, Puerto Rico

Research Site, Cidra, Puerto Rico

Research Site, Levittown, Puerto Rico

Research Site, Ponce, Puerto Rico

Research Site, SanJuan, Puerto Rico

Research Site, Trujillo Alto, Puerto Rico

Research Site, Anaheim, California, United States

Research Site, Chula Vista, California, United States

Research Site, Fresno, California, United States

Research Site, Fullerton, California, United States

Research Site, Los Angeles, California, United States

Research Site, National City, California, United States

Research Site, Rancho Cordova, California, United States

Research Site, Rancho Mirage, California, United States

Research Site, Riverside, California, United States

Research Site, Sacramento, California, United States

Research Site, San Diego, California, United States

Research Site, San Francisco, California, United States

Research Site, Stockton, California, United States

Research Site, Torrance, California, United States

Research Site, Pueblo, Colorado, United States

Research Site, Largo, Florida, United States

Research Site, Miami, Florida, United States

Research Site, Naranja, Florida, United States

Research Site, North Miami, Florida, United States

Research Site, Orlando, Florida, United States

Research Site, Panama City, Florida, United States

Research Site, South Miami, Florida, United States

Research Site, Chicago, Illinois, United States

Research Site, Newburgh, New York, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Boerne, Texas, United States

Research Site, El Paso, Texas, United States

Research Site, Fort Worth, Texas, United States

Research Site, Houston, Texas, United States

Research Site, San Antonio, Texas, United States

Research Site, Spring, Texas, United States

Starting date: January 2007
Ending date: June 2008
Last updated: March 20, 2008