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

AstraZeneca1 site in 1 country311 target enrollmentJune 2008

ConditionsAsthma

InterventionsBudesonide / formoterol fumarate (SYMBICORT)Budesonide

DrugsBudesonide / formoterol fumarate (SYMBICORT)Budesonide

Overview

Phase: Phase 4
Intervention: Budesonide / formoterol fumarate (SYMBICORT)
Conditions: Asthma
Sponsor: AstraZeneca
Enrollment: 311
Locations: 1
Primary Endpoint: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

September 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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
•Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit
•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

Arms & Interventions

1

Intervention: Budesonide / formoterol fumarate (SYMBICORT)

2

Intervention: Budesonide

Outcomes

Primary Outcomes

Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period

Time Frame: Baseline to 12 weeks

Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Secondary Outcomes

Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period(Baseline to 12 weeks)
Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry(12 weeks)
Number of Withdrawals Due to a Predefined Asthma Event(12 weeks)
Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period(Baseline to 12 weeks)
Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period(Baseline to 12 weeks)
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)(12 week)
Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])(Baseline to 12 weeks)
Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment(12 weeks)
Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)(Baseline to 12 weeks)
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)(12 week)
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)(1 week)
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)(1 week)