Phase 3
Completed N=107
Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma
Source: ClinicalTrials.gov NCT00536913 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcomePrimary: Urinary Free Cortisol (UFC) — 0.86; 1.03 Ratio
Summary
The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Free Cortisol (UFC) |
0.86; 1.03 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) |
0.17; 0.14 | — |
| SECONDARY Morning Peak Expiratory Flow (mPEF) |
28.70; 19.50 | — |
| SECONDARY Evening Peak Expiratory Flow (ePEF) |
27.00; 15.30 | — |
| SECONDARY Asthma Symptoms at Night |
-0.20; -0.21 | — |
| SECONDARY Asthma Symptoms at Day |
-0.25; -0.28 | — |
| SECONDARY Percentage of Nights With Awakenings Due to Asthma |
-13.80; -8.20 | — |
| SECONDARY Use of Rescue Medication at Night |
-0.21; -0.14 | — |
| SECONDARY Use of Rescue Medication at Day |
-0.30; -0.19 | — |
Eligibility Criteria
Inclusion Criteria
- children 6-11 years, diagnosed asthma treated
- 6 months, PEF
- 50% of predicted normal value pre-bronchodilator
Exclusion Criteria
- current systemic glucocorticosteroids usage
- current respiratory infection
- any significant disease or disorder as judged by investigator
Data sourced from ClinicalTrials.gov (NCT00536913). 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.