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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide HFA pMDI; Drug: Budesonide/formoterol (SYMBICORT) pMDI

• Registration Number: NCT00419757
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-09
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-05-20
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-24
• Last Update Submitted: 2012-08-24
• Results First Posted: 2012-08-27
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 558

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide	Budesonide HFA pMDI	budesonide HFA pMDI 160 μg x 2 actuations twice daily
Symbicort	Budesonide/formoterol (SYMBICORT) pMDI	SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily

Primary Outcome Measures

Name	Time	Method
Morning Peak Expiratory Flow (AM PEF)	Baseline (run-in) and throughout 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Pre-defined Asthma Events	12 weeks	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
Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"	12 weeks	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.
Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)	Baseline, 2, 6 and 12 weeks	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.
Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)	Baseline (run-in) and throughout 12 weeks	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.
Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks	Baseline (run-in) and throughout 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
Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks	Baseline (run-in) and throughout 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
Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks	Baseline (run-in) and throughout 12 weeks	Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.
Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment	Baseline (run-in) and throughout 12 weeks	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.
Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment	Baseline (run-in) and throughout 12 weeks	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.
Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment	Baseline (run-in) and throughout 12 weeks	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.
Subject Global Assessment	Baseline and week 12	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.
Physician Global Assessment	Baseline and week 12	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.
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index	Week 12	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.
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication	Week 12	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.
Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications	Week 12	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.

Trial Locations

Locations (1)

Research Site; 🇵🇷 Trujillo Alto, Puerto Rico