A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3)
3 other identifiers
interventional
583
0 countries
N/A
Brief Summary
The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second \[FEV1\]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jan 2012
Longer than P75 for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2011
CompletedFirst Posted
Study publicly available on registry
December 30, 2011
CompletedStudy Start
First participant enrolled
January 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2015
CompletedResults Posted
Study results publicly available
October 6, 2015
CompletedJune 17, 2024
February 1, 2022
3 years
December 28, 2011
September 1, 2015
June 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.
Baseline and Week 12
Secondary Outcomes (3)
Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo
Baseline and Week 12
Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo
Baseline and Week 12
Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD
Baseline and Week 12
Study Arms (5)
MF MDI 50 mcg BID
EXPERIMENTALParticipants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
MF MDI 100 mcg BID
EXPERIMENTALParticipants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
MF MDI 200 mcg BID
EXPERIMENTALParticipants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
MF DPI 100 mcg QD
ACTIVE COMPARATORParticipants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
Placebo
PLACEBO COMPARATORParticipants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
Interventions
MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks
MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks
MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks
MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks
Placebo DPI, 1 puff QD for 12 weeks
Eligibility Criteria
You may qualify if:
- Diagnosis of asthma of at least 6 months duration.
- Using an Inhaled corticosteroid (ICS), either alone or in combination with a long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit and must have been on a stable asthma regimen for at least 2 weeks prior to the Screening Visit, must not have used oral glucocorticosteroids within 30 days of the Screening Visit.
You may not qualify if:
- Treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalization for management of airway obstruction within 3 months prior to the Screening Visit.
- History of ventilator support for respiratory failure secondary to asthma.
- Upper or lower respiratory tract infection (viral or bacterial) within the 2 weeks prior to Screening and Baseline Visits.
- History of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study or require treatment that might interfere with the study. Specific examples include but are not limited to insulin-dependent diabetes, hypertension, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis. Other conditions that are well controlled and stable will not prohibit participation if deemed appropriate per the investigator's judgment.
- Inability to correctly use an oral MDI or a DPI.
- Participation in this study at another investigational site. Participation in a different investigational study at any site during the same time frame of this study.
- Randomization into this study more than once.
- Direct association with either the administration of the this study or the study staff.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Amar NJ, Shekar T, Varnell TA, Mehta A, Philip G. Mometasone furoate (MF) improves lung function in pediatric asthma: A double-blind, randomized controlled dose-ranging trial of MF metered-dose inhaler. Pediatr Pulmonol. 2017 Mar;52(3):310-318. doi: 10.1002/ppul.23563. Epub 2016 Oct 14.
PMID: 27740721RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2011
First Posted
December 30, 2011
Study Start
January 25, 2012
Primary Completion
January 29, 2015
Study Completion
January 29, 2015
Last Updated
June 17, 2024
Results First Posted
October 6, 2015
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share