Phase 3
Completed N=279
A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg
Source: ClinicalTrials.gov NCT02091986 ↗Enrolled (actual)
279
Serious AEs
0.7%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline to Week 12 in 1h Post-dose FEV1 — 0.28; 0.24; 0.17 Liters — p=0.006
◆ Published Evidence
Emerging
17citations · ~2 / year
Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6-<12 years).
Summary
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma during 12 weeks.
Linked Publications
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Efficacy and safety of budesonide/formoterol pMDI vs budesonide pMDI in asthmatic children (6-<12 years).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in 1h Post-dose FEV1 |
0.28; 0.24; 0.17 | 0.006 sig |
| SECONDARY Change From Baseline to Week 12 in 1h Post-dose PEF |
57.04; 41.14; 31.57 | 0.001 sig |
| SECONDARY Change From Baseline to Week 12 in 1h Post-dose FEF25-75 |
0.55; 0.47; 0.23 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 in 1h Post-dose FVC |
0.22; 0.16; 0.17 | 0.276 |
| SECONDARY Change From Baseline to Week 12 in Pre-dose FEV1 |
0.11; 0.10; 0.09 | 0.724 |
| SECONDARY Change From Baseline to Week 12 in Pre-dose PEF |
27.73; 15.86; 16.01 | 0.134 |
| SECONDARY Change From Baseline to Week 12 in Pre-dose FEF25-75 |
0.12; 0.13; 0.09 | 0.684 |
| SECONDARY Change From Baseline to Week 12 in Pre-dose FVC |
0.11; 0.11; 0.13 | 0.664 |
| SECONDARY Change From Baseline to Week 12 in 15 Min Post-dose FEV1 |
0.25; 0.19; 0.15 | 0.015 sig |
| SECONDARY Change From Baseline to End of Study Average in Total Asthma Symptoms |
-0.5; -0.6; -0.4 | — |
| SECONDARY Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms |
-14.0; -17.3; -13.0 | — |
| SECONDARY Change From Baseline to End of Study Average in Total Daily Reliever Medication |
-0.7; -1.1; -0.7 | — |
| SECONDARY Change From Baseline to Study Period Average in Overall PAQLQ Score |
0.46; 0.53; 0.62 | 0.098 |
| SECONDARY Number of Patients With an Asthma Exacerbation During Study |
9; 12; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2
- Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
- Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.
Exclusion Criteria
- Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
- Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1
Data sourced from ClinicalTrials.gov (NCT02091986) and the linked publication. 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.