Phase 3
Completed N=250
An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
Source: ClinicalTrials.gov NCT00419757 ↗Enrolled (actual)
250
Serious AEs
1.6%
Results posted
Aug 2012
Primary outcomePrimary: Morning Peak Expiratory Flow (AM PEF) — 25.40; 19.90 Liters/minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morning Peak Expiratory Flow (AM PEF) |
25.40; 19.90 | — |
| SECONDARY Percentage of Participants With Pre-defined Asthma Events |
25.20; 31.70 | — |
| SECONDARY Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events" |
2.10; 6.50 | — |
| SECONDARY Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1) |
0.16; 0.11 | — |
| SECONDARY Change From Baseline in a Evening Peak Expiratory Flow (PM PEF) |
20.60; 15.80 | — |
| SECONDARY Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks |
-0.40; -0.30 | — |
| SECONDARY Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks |
-0.40; -0.30 | — |
| SECONDARY Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks |
5.40; 5.50 | — |
| SECONDARY Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment |
-0.80; -0.60 | — |
| SECONDARY Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment |
19.70; 17.70 | — |
| SECONDARY Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment |
24.40; 21.00 | — |
| SECONDARY Subject Global Assessment |
88.70; 86.30 | — |
| SECONDARY Physician Global Assessment |
92.00; 84.60 | — |
| SECONDARY Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index |
87.20; 82.50 | — |
| SECONDARY Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication |
90.67; 86.66 | — |
| SECONDARY Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications |
88.45; 80.60 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00419757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.