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)

NCT02741271 | Completed Phase 3 Results

• 3 other identifiers: 0887A-087MK-0887A-0872009-010110-30
• Study Type: interventional
• Target: 181
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• 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

  This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.

  Baseline, and average of Day 1, Weeks 1, 4, 8, and 12

• Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)

  An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.

  Up to 26 weeks

• Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE

  An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.

  Up to 24 weeks

Secondary Outcomes (10)

• Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment

  Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points

• Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment

  Baseline, Day 1 and Week 12

• 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

  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

  Baseline and Weeks 1-12 (Averaged)

• Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period

  Baseline and Weeks 1-12 (Averaged)

Study Arms (2)

MF/F MDI 100/10 mcg BID

EXPERIMENTAL

Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks.

Drug: MF MDI 100 mcg BID (Open Label); Drug: MF/F MDI 100/10 mcg BID; Drug: Albuterol/Salbutamol PRN; Drug: Prednisone/Prednisolone

MF MDI 100 mcg BID

ACTIVE COMPARATOR

Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks.

Drug: MF MDI 100 mcg BID (Open Label); Drug: MF MDI 100 mcg BID; Drug: Albuterol/Salbutamol PRN; Drug: Prednisone/Prednisolone

Interventions

MF MDI 100 mcg BID (Open Label) DRUG

Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.

Also known as: ASMANEX HFA®, SCH 032088 (MK-0887)

MF MDI 100 mcg BID; MF/F MDI 100/10 mcg BID

MF/F MDI 100/10 mcg BID DRUG

After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF/F MDI 100/10 mcg BID.

Also known as: DULERA®/ZENHALE®, SCH 418131 (MK-0887A)

MF/F MDI 100/10 mcg BID

MF MDI 100 mcg BID DRUG

After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF MDI 100 mcg BID.

Also known as: ASMANEX HFA®, SCH 032088 (MK-0887)

MF MDI 100 mcg BID

Albuterol/Salbutamol PRN DRUG

Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms.

MF MDI 100 mcg BID; MF/F MDI 100/10 mcg BID

Prednisone/Prednisolone DRUG

Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion.

MF MDI 100 mcg BID; MF/F MDI 100/10 mcg BID

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 32022483 RESULT

MeSH Terms

Conditions

Asthma

Interventions

BID protein, human; Albuterol; Prednisone; Prednisolone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 1:1 randomization to double-blinded MF/F MDI 100/10 mcg BID and MF MDI 100 mcg BID
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 18, 2016
• Study Start: May 11, 2016
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: May 16, 2024
• Results First Posted: May 22, 2019

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share