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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00419757
First received: January 5, 2007
Last updated: August 24, 2012
Last verified: August 2012
History of Changes
Results First Received: May 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Budesonide/formoterol (SYMBICORT) pMDI
Drug: Budesonide HFA pMDI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
39 centres in United States enrolled 558 patients with asthma into this study. 308 patients were excluded: 279 for incorrect enrollment/eligibility criteria not fulfilled, 14 for voluntary discontinuations, 2 for development of study specific discontinuation criteria, 2 for adverse events, 10 were lost to follow-up

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Male or female, Hispanic (self-reported), ≥12 years

Reporting Groups
  Description
Symbicort SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Participant Flow:   Overall Study
    Symbicort     Budesonide  
STARTED     127 [1]   123 [1]
COMPLETED     109 [1]   102 [1]
NOT COMPLETED     18     21  
Adverse Event                 1                 4  
Lost to Follow-up                 1                 4  
Withdrawal by Subject                 7                 1  
Protocol Violation                 2                 3  
Study specific discontinuation criteria                 4                 8  
Multiple reasons                 3                 1  
[1] Randomized patients



  Baseline Characteristics
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Reporting Groups
  Description
Symbicort SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Total Total of all reporting groups

Baseline Measures
    Symbicort     Budesonide     Total  
Number of Participants  
[units: participants]
 		  127     123     250  
Age  
[units: Years]
Mean ± Standard Deviation 		  16.6  ± 39.8     14.9  ± 37.0     15.6  ± 38.4  
Gender  
[units: Participants]
 		     
Female     84     80     164  
Male     43     43     86  



  Outcome Measures
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1.  Primary:   Morning Peak Expiratory Flow (AM PEF)   [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
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2.  Secondary:   Percentage of Participants With Pre-defined Asthma Events   [ Time Frame: 12 weeks ]
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3.  Secondary:   Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"   [ Time Frame: 12 weeks ]
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4.  Secondary:   Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Baseline, 2, 6 and 12 weeks ]
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5.  Secondary:   Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)   [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
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6.  Secondary:   Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks   [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
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7.  Secondary:   Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks   [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
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8.  Secondary:   Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks   [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
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9.  Secondary:   Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment   [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
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10.  Secondary:   Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment   [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
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11.  Secondary:   Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment   [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
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12.  Secondary:   Subject Global Assessment   [ Time Frame: Baseline and week 12 ]
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13.  Secondary:   Physician Global Assessment   [ Time Frame: Baseline and week 12 ]
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14.  Secondary:   Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index   [ Time Frame: Week 12 ]
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15.  Secondary:   Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication   [ Time Frame: Week 12 ]
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16.  Secondary:   Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications   [ Time Frame: Week 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00419757     History of Changes
Other Study ID Numbers: D5896C00021
Study First Received: January 5, 2007
Results First Received: May 20, 2009
Last Updated: August 24, 2012
Health Authority: United States: Food and Drug Administration