Phase 2
Completed N=304
A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo
Source: ClinicalTrials.gov NCT01136382 ↗Enrolled (actual)
304
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average — 4.1; 17.8 liters/minute — p=<0.0001
Summary
This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to <12 years
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average |
4.1; 17.8 | <0.0001 sig |
| SECONDARY Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average |
0.00; 0.06 | 0.0047 sig |
| SECONDARY Change in Evening PEF From Baseline to the Treatment Period Average |
4.0; 14.7 | 0.0004 sig |
| SECONDARY Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average |
0.00; 0.04 | 0.0673 |
| SECONDARY Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average |
0.01; 0.11 | 0.0216 sig |
| SECONDARY Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average |
-0.2; -0.4; -0.5; -0.8 | 0.0004 sig |
| SECONDARY Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average |
-0.3; -0.4 | 0.0079 sig |
| SECONDARY Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average |
-9.8; -14.5; -6.1; -10.0 | 0.0095 sig |
| SECONDARY Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average |
-0.1; -0.4; -0.3; -0.7 | 0.0001 sig |
| SECONDARY Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average |
-0.1; -0.4 | <0.0001 sig |
| SECONDARY Number of Withdrawals Due to Pre-defined Asthma Events |
50; 25 | 0.0004 sig |
Eligibility Criteria
Inclusion Criteria
- Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 2 that has required daily inhaled corticosteroid in the low dose range OR LTRA as monotherapy for at least 30 days prior to Visit 2.
- Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled short acting beta agonist of greater than or equal to 70% and less than or equal to 95% of predicted normal
- Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit 2.
Exclusion Criteria
- Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma-related condition during the 6 months prior to Visit 2
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 2
Data sourced from ClinicalTrials.gov (NCT01136382). 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.