An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide/formoterol (SYMBICORT) pMDI; Drug: Budesonide HFA pMDI

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • 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
• United States
  • California
    • 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
  • Colorado
    • Pueblo, Colorado, United States
      • Research Site
  • Florida
    • 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
  • Illinois
    • Chicago, Illinois, United States
      • Research Site
  • New York
    • Newburgh, New York, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Research Site
  • Texas
    • 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
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Symbicort; SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily	Drug: Budesonide/formoterol (SYMBICORT) pMDI; SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Active Comparator: Budesonide; budesonide HFA pMDI 160 μg x 2 actuations twice daily	Drug: Budesonide HFA pMDI; Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morning Peak Expiratory Flow (AM PEF)	Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.	Baseline (run-in) and throughout 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Pre-defined Asthma Events	Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication	12 weeks
Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"	Percentage of participants with "Withdrawals Due to Pre-defined Asthma Events" as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	12 weeks
Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)	Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline, 2, 6 and 12 weeks
Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)	Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline (run-in) and throughout 12 weeks
Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks	Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate. Daily scale: 0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms	Baseline (run-in) and throughout 12 weeks
Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks	Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate. Daily scale: 0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms	Baseline (run-in) and throughout 12 weeks
Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks	Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.	Baseline (run-in) and throughout 12 weeks
Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment	Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline (run-in) and throughout 12 weeks
Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment	Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline (run-in) and throughout 12 weeks
Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment	Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.	Baseline (run-in) and throughout 12 weeks
Subject Global Assessment	The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.	Baseline and week 12
Physician Global Assessment	The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as "Yes" and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.	Baseline and week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index	Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.	Week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication	Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.	Week 12
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications	Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.	Week 12

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Christer Hultquist, MD, AstraZeneca

Publications and helpful links

General Publications

• 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. Erratum In: Drugs R D. 2012 Mar 1;12(1):15.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 5, 2007
• First Submitted That Met QC Criteria: January 5, 2007
• First Posted (Estimate): January 9, 2007

Study Record Updates

• Last Update Posted (Estimate): August 27, 2012
• Last Update Submitted That Met QC Criteria: August 24, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Moderate asthma; Severe asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: D5896C00021