Clinical trial NCT00419757: An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Moderate asthma
Severe asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 558
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Morning Peak Expiratory Flow (AM PEF)
timeFrame: Baseline (run-in) and throughout 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Pre-defined Asthma Events
timeFrame: 12 weeks
measure: Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"
timeFrame: 12 weeks
measure: Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, 2, 6 and 12 weeks
measure: Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)
timeFrame: Baseline (run-in) and throughout 12 weeks
measure: Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks
timeFrame: Baseline (run-in) and throughout 12 weeks
measure: Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks
timeFrame: Baseline (run-in) and throughout 12 weeks
measure: Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks
timeFrame: Baseline (run-in) and throughout 12 weeks
measure: Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment
timeFrame: Baseline (run-in) and throughout 12 weeks
measure: Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment
timeFrame: Baseline (run-in) and throughout 12 weeks
measure: Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment
timeFrame: Baseline (run-in) and throughout 12 weeks
measure: Subject Global Assessment
timeFrame: Baseline and week 12
measure: Physician Global Assessment
timeFrame: Baseline and week 12
measure: Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index
timeFrame: Week 12
measure: Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication
timeFrame: Week 12
measure: Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications
timeFrame: Week 12
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Fullerton
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: National City
country: United States
facility: Research Site
state: California
city: Rancho Cordova
country: United States
facility: Research Site
state: California
city: Rancho Mirage
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Pueblo
country: United States
facility: Research Site
state: Colorado
city: Largo
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Naranja
country: United States
facility: Research Site
state: Florida
city: North Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Panama City
country: United States
facility: Research Site
state: Florida
city: South Miami
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Newburgh
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Boerne
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Spring
country: United States
facility: Research Site
state: Texas
city: Aguas Buenas
country: Puerto Rico
facility: Research Site
city: Caquas
country: Puerto Rico
facility: Research Site
city: Cidra
country: Puerto Rico
facility: Research Site
city: Levittown
country: Puerto Rico
facility: Research Site
city: Ponce
country: Puerto Rico
facility: Research Site
city: SanJuan
country: Puerto Rico
facility: Research Site
city: Trujillo Alto
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Christer Hultquist, MD
role: STUDY_DIRECTOR
References:
citation: Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
citation: Zangrilli J, Mansfield LE, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. Ann Allergy Asthma Immunol. 2011 Sep;107(3):258-65.e2. doi: 10.1016/j.anai.2011.05.024. Epub 2011 Jul 14.