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)

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT02741271
• Date of registration: 13/04/2016
• Prospective Registration: Yes
• Primary sponsor: Organon and Co
• Public title: 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)
• Scientific 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
• Date of first enrolment: May 11, 2016
• Target sample size: 181
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02741271
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Colombia, Denmark, Guatemala, Hungary, Latvia, Mexico, Romania, Russian Federation, South Africa, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: MF MDI 100 mcg BID

Drug: MF/F MDI 100/10 mcg BID

Drug: MF MDI 100 mcg BID (Open Label)

Drug: Albuterol/Salbutamol PRN

Drug: Prednisone/Prednisolone

Primary Outcome(s)

Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE [Time Frame: Up to 24 weeks]

Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE) [Time Frame: Up to 26 weeks]

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 [Time Frame: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12]

Secondary Outcome(s)

Maximum Plasma Concentration (Cmax) of Mometsone Furoate [Time Frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12]

Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period [Time Frame: Weeks 1-12 (Averaged)]

Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate [Time Frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12]

Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12) [Time Frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12]

Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last) [Time Frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12]

Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment [Time Frame: Baseline, Day 1 and Week 12]

Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment [Time Frame: Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points]

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 [Time Frame: Baseline and Weeks 4, 8, and 12 (Averaged)]

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 [Time Frame: Baseline and Weeks 1-12 (Averaged)]

Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period [Time Frame: Baseline and Weeks 1-12 (Averaged)]

Secondary ID(s)

MK-0887A-087

2009-010110-30

0887A-087

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02741271