Phase 3
Completed N=181
Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination With Formoterol Fumarate Versus Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)
Source: ClinicalTrials.gov NCT02741271 ↗Enrolled (actual)
181
Serious AEs
1.7%
Results posted
May 2019
Primary outcomePrimary: Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60 — 79.21; 78.48; 8.99; 3.96 Percent predicted FEV1 — p=<0.001
◆ Published Evidence
Emerging
5citations · ~1 / year
A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma.
Summary
This study compares the 12-week efficacy and 24-week safety of mometasone furoate/formoterol fumarate (MF/F) 100/10 mcg and mometasone furate (MF) 100 mcg, both administered twice daily (BID) via metered-dose inhaler (MDI) in children aged 5 to 11 years with persistent asthma.
Linked Publications
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A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60 |
79.21; 78.48; 8.99; 3.96 | <0.001 sig |
| PRIMARY Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE) |
37; 52; 89 | — |
| PRIMARY Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE |
0; 3; 3 | — |
| SECONDARY Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment |
79.21; 78.48; 11.61; 5.68; 12.71; 5.87 | <0.001 sig |
| SECONDARY Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment |
79.21; 78.48; 7.13; 2.70; 7.56; 4.87 | <0.001 sig |
| SECONDARY Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment |
79.21; 78.22; 1.51; 0.44 | 0.197 |
| SECONDARY Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment |
0.25; 0.13; -0.12; -0.02 | — |
| SECONDARY Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period |
23; 17; 41; 45 | — |
| SECONDARY Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period |
24; 34 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12) |
109 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last) |
106 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Mometsone Furoate |
16 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate |
1.47 | — |
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines
- Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks
- Is able to demonstrate an FEV1 >60% and ≤90% predicted
- Is able to demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol/salbutamol.
- Is able to use an MDI (without spacer), use a peak flow meter, and perform spirometry correctly.
- Is willing (with consent of their parent(s)/guardian) to discontinue previously prescribed asthma medication, if there is no inherent harm in changing the participant's current asthma therapy.
- Has laboratory tests that are clinically acceptable to the investigator.
Exclusion Criteria
- Requires >8 inhalations per day of albuterol (100 mcg per actuation), and/or >2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days
- Has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) between the Screening and Baseline visits.
- Is considered by the investigator to have unstable asthma at the end of the run-in period
- Has had > 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1
- Has had a history of life-threatening asthma
- Has a clinically significant condition or situation, other than the condition being studied which may interfere with trial evaluations, participant safety, or optimal participation in the trial
Data sourced from ClinicalTrials.gov (NCT02741271) 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.