Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

Asthma Clinical Trial

— Titan  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702325
• Other study ID #: D589BL00003
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2008
• Last updated: October 10, 2012
• Start date: June 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 ß2-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide / formoterol fumarate (SYMBICORT)
160/4.5 µg x 2 actuations twice daily (bid)
• Budesonide
inhalation powder 180 µg x 2 inhalations bid (PULMICORT)

Locations

Country	Name	City	State
United States	Research Site	Alpharetta	Georgia
United States	Research Site	Arlington	Texas
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bentonville	Arkansas
United States	Research Site	Blue Bell	Pennsylvania
United States	Research Site	Centennial	Colorado
United States	Research Site	Charleston	South Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Dallas	Texas
United States	Research Site	Decatur	Georgia
United States	Research Site	Durham	North Carolina
United States	Research Site	Emporia	Virginia
United States	Research Site	Flint	Michigan
United States	Research Site	Fort Worth	Texas
United States	Research Site	Ft. Worth	Texas
United States	Research Site	Greenville	North Carolina
United States	Research Site	Hagerstown	Maryland
United States	Research Site	Hot Springs	Arkansas
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Park	California
United States	Research Site	Inverness	Florida
United States	Research Site	Kansas City	Missouri
United States	Research Site	Lanham	Maryland
United States	Research Site	Largo	Maryland
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lawrenceville	Georgia
United States	Research Site	Lithia Springs	Georgia
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angles	California
United States	Research Site	Lovejoy	Georgia
United States	Research Site	Malvern	Arkansas
United States	Research Site	McKinney	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	New York	New York
United States	Research Site	North Syracuse	New York
United States	Research Site	Ocala	Florida
United States	Research Site	Orange	California
United States	Research Site	Pell City	Alabama
United States	Research Site	Plano	Texas
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Rolling Hills Estates	California
United States	Research Site	San Antonio	Texas
United States	Research Site	Skillman	New Jersey
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	St. Louis	Missouri
United States	Research Site	Tallahassee	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Towson	Maryland
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Waco	Texas
United States	Research Site	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period	Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period	Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period	Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period	Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period	Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.	Baseline to 12 weeks	No
Secondary	Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry	Total number of participants with any first predefined asthma event (decrease in FEV1 = 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF = 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)	12 weeks	No
Secondary	Number of Withdrawals Due to a Predefined Asthma Event	Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 = 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF = 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)	12 weeks	No
Secondary	Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period	Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period	Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)	Baseline to 12 weeks	No
Secondary	Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period	Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)	Baseline to 12 weeks	No
Secondary	Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period	Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period	Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period	Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period	Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period	Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period	Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period	Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	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)	Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away	12 week	No
Secondary	Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])	Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period	Baseline to 12 weeks	No
Secondary	Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment	There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.	12 weeks	No
Secondary	Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)	There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.	Baseline to 12 weeks	No
Secondary	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)	Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.	12 week	No
Secondary	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)	Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away	1 week	No
Secondary	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)	Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.	1 week	No