Clinical trial NCT01502371: A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Children
Persistent
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-12-30
Enrollment: 583
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo
timeFrame: Baseline and Week 12
measure: Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo
timeFrame: Baseline and Week 12
measure: Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.