Phase 2
N=578
A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01502371 ↗Enrolled (actual)
578
Serious AEs
1.9%
Results posted
Oct 2015
Primary outcome: Primary: Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo — 4.52; 6.95; 6.00; 0.66 Percentage of Predicted FEV1 — p=0.019
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg (Drug); Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg (Drug); Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg (Drug); Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg (Drug); Placebo Metered Dose Inhaler (MDI) (Drug); Placebo Dry Powder Inhaler (DPI) (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo |
4.52; 6.95; 6.00; 0.66 | 0.019 sig |
| SECONDARY Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo |
17.83; 26.03; 16.68; -1.32; -0.92 | 0.045 sig |
| SECONDARY Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo |
0.35; 0.38; 0.44; 0.26; 0.47 | 0.280 |
| SECONDARY Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD |
4.52; 3.13 | 0.368 |
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.
Data sourced from ClinicalTrials.gov (NCT01502371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.