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

Phase 3CompletedNCT00419757

AstraZeneca558 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

558

Conditions

Asthma

Interventions

Budesonide/formoterol (SYMBICORT) pMDIDRUG

SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily

Budesonide HFA pMDIDRUG

Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (39)

Outcomes

Primary Outcomes

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.

Time frame: Baseline (run-in) and throughout 12 weeks

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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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

...and 29 more locations

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Week 12