Clinical trial NCT02741271: 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)
Official title: A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Children With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 181
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12
measure: Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)
timeFrame: Up to 26 weeks
measure: Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment
timeFrame: Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points
measure: Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment
timeFrame: Baseline, Day 1 and Week 12
measure: 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
timeFrame: Baseline and Weeks 4, 8, and 12 (Averaged)
measure: 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
timeFrame: Baseline and Weeks 1-12 (Averaged)
measure: Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period
timeFrame: Baseline and Weeks 1-12 (Averaged)
measure: Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period
timeFrame: Weeks 1-12 (Averaged)
measure: Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12)
timeFrame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
measure: Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last)
timeFrame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
measure: Maximum Plasma Concentration (Cmax) of Mometsone Furoate
timeFrame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
measure: Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate
timeFrame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Weinstein CLJ, Gates D, Zhang X, Varnell T, Mok W, Vermeulen JH, Amar NJ, Jain N. A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma. Pediatr Pulmonol. 2020 Apr;55(4):882-889. doi: 10.1002/ppul.24667. Epub 2020 Feb 5.