A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
Summary
A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant was to receive a single dose of each of 4 treatments in each period. Each treatment period was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10 microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a significant increase in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours (AUC\[0-12 hr\]) when compared to placebo.
Timeline
- Start
- 2010-12
- Primary completion
- 2011-10
- Completion
- 2011-10
Outcome
Met primary endpoint
registry MF/F MDI With Spacer vs Placebo MDI With or Without Spacer; p <0.001; Mean Difference (Final Values) 0.124 (95% CI 0.094 to 0.154) NCT01258803 ↗
paper MF/F with spacer demonstrated a larger change in mean FEV1 AUC0-12hr versus placebo (115 vs. -9 mL), with a treatment difference of 124 mL (95% CI 94-154, P < 0.001). PMID 24019197 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Formoterol | Other / unclassified | 5 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 10 ug | Inhaled |
| Background | Mometasone | Other / unclassified | 50 ug | Inhaled |
| Background | Mometasone | Other / unclassified | 100 ug | Inhaled |
| Background | Mometasone | Other / unclassified | 100 ug | Inhaled |