- ICH GCP
- US Clinical Trials Registry
- 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)
February 7, 2022 updated by: Organon and Co
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
181
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MF/F MDI 100/10 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks.
|
Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.
Other Names:
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.
Other Names:
Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms.
Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion.
|
Active Comparator: MF MDI 100 mcg BID
Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks.
|
Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.
Other Names:
Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms.
Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
Time Frame: Up to 26 weeks
|
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
Time Frame: Up to 24 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
The key secondary objective was to determine the onset of action for the efficacy of MF/F MDI 100/10 mcg BID, compared with MF MDI 100 mcg BID.
The post-dose AM % predicted FEV1 was averaged sequentially, and the change from baseline on Day 1 was assessed.
This key secondary endpoint was controlled for multiplicity in a step-down fashion, based on trial success defined as a statistically significant improvement in the primary endpoint for MF/F vs MF.
Missing data were imputed using control-based multiple imputations with the cLDA model.
|
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
Time Frame: Baseline, Day 1 and Week 12
|
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 4 hours post-dose on Day 1 and Week 12 compared to Baseline.
Baseline was the average of 30 and 0 minutes pre-dose % predicted FEV1 values.
The AUC was calculated over the scheduled timepoints of 0 min, 5 min, 15 min, 30 min, 60 min, 2 hr and 4 hr post-dose.
Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.
|
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
Time Frame: Baseline and Weeks 4, 8, and 12 (Averaged)
|
The change from baseline in AM pre-dose % predicted FEV1 with MF/F MDI 100/10 mcg BID vs MF MDI 100 mcg BID averaged over 12 weeks treatment was assessed.
This secondary analysis of the change from baseline used the cLDA method without multiple imputation.
A model-based MAR approach was used for missing data.
|
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)
|
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the change from baseline in total daily short-acting beta-agonist (SABA) use (puffs per day) was averaged and assessed.
All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms.
This secondary analysis of the change from baseline used the cLDA method without multiple imputation.A model-based MAR approach was used for missing data.
|
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)
|
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants using SABA rescue medication in Weeks 1-12 (individually) of the double-blind treatment period was assessed.
All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms.
|
Baseline and Weeks 1-12 (Averaged)
|
Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period
Time Frame: Weeks 1-12 (Averaged)
|
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants whose use of SABA rescue medication increased in Weeks 1-12 (individually) of the double-blind treatment period was assessed.
All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for relief of asthma symptoms.
|
Weeks 1-12 (Averaged)
|
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
|
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial.
Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.
|
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
|
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial.
Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.
|
Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
|
Maximum Plasma Concentration (Cmax) of Mometsone Furoate
Time Frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
|
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial.
Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.
|
Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
|
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
|
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial.
Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.
|
Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2016
Primary Completion (Actual)
December 4, 2017
Study Completion (Actual)
December 4, 2017
Study Registration Dates
First Submitted
April 13, 2016
First Submitted That Met QC Criteria
April 13, 2016
First Posted (Estimate)
April 18, 2016
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Prednisolone
- Prednisone
- Albuterol
- Mometasone Furoate
Other Study ID Numbers
- 0887A-087
- MK-0887A-087 (Other Identifier: Merck Registration Number)
- 2009-010110-30 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on MF MDI 100 mcg BID (Open Label)
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoNovartisCompleted
-
Organon and CoNovartisCompleted
-
AstraZenecaRecruitingAsthmaUnited States, Canada, Italy, Japan, Vietnam, Spain, Germany, Malaysia
-
Children's Hospital Medical Center, CincinnatiNational Institutes of Health (NIH); Regeneron PharmaceuticalsActive, not recruitingEosinophilic Gastritis | Eosinophilic GastroenteritisUnited States