Clinical trial NCT00702325: Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 311
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: 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry
timeFrame: 12 weeks
measure: Number of Withdrawals Due to a Predefined Asthma Event
timeFrame: 12 weeks
measure: Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period
timeFrame: Baseline to 12 weeks
measure: Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)
timeFrame: 12 week
measure: Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])
timeFrame: Baseline to 12 weeks
measure: Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment
timeFrame: 12 weeks
measure: Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)
timeFrame: Baseline to 12 weeks
measure: Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)
timeFrame: 12 week
measure: Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)
timeFrame: 1 week
measure: Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)
timeFrame: 1 week
Other outcomes:
Locations:
city: Pell City
country: United States
facility: Research Site
state: Alabama
city: Bentonville
country: United States
facility: Research Site
state: Arkansas
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Malvern
country: United States
facility: Research Site
state: Arkansas
city: Huntington Park
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angles
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Rolling Hills Estates
country: United States
facility: Research Site
state: California
city: Centennial
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Inverness
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Alpharetta
country: United States
facility: Research Site
state: Georgia
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Lawrenceville
country: United States
facility: Research Site
state: Georgia
city: Lithia Springs
country: United States
facility: Research Site
state: Georgia
city: Lovejoy
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Lanham
country: United States
facility: Research Site
state: Maryland
city: Largo
country: United States
facility: Research Site
state: Maryland
city: Towson
country: United States
facility: Research Site
state: Maryland
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Skillman
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: North Syracuse
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Blue Bell
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Arlington
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Ft. Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: McKinney
country: United States
facility: Research Site
state: Texas
city: Plano
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Waco
country: United States
facility: Research Site
state: Texas
city: Emporia
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Ubaldo Martin, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Tomas LG Andersson
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.