Phase 2
Completed N=54
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
Source: ClinicalTrials.gov NCT01136655 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1) — 1.546; 1.594; 1.603; 1.489 liters — p=<0.0001
Summary
This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1) |
1.546; 1.594; 1.603; 1.489; 1.603 | <0.0001 sig |
| SECONDARY FEV1 at 12 Hours After Study Medication Inhalation |
1.641; 1.692; 1.731; 1.626; 1.709 | <0.0001 sig |
| SECONDARY Maximal FEV1 During the 12-hour Study Period |
1.833; 1.889; 1.884; 1.777; 1.892 | <0.0001 sig |
| SECONDARY Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug |
192.0; 366.3; 740.6; 658.7 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 1
- Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =85% of predicted normal.
- Demonstrated reversibility of FEV1 of =15% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist
Exclusion Criteria
- Has been hospitalized for >24 hours at least once or required emergency treatment or urgent care visit more than once for an asthma-related condition during the 6 months prior to Visit 1
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1.
Data sourced from ClinicalTrials.gov (NCT01136655). 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.