Asthma MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Mometasone Furoate (MF) Pressured Metered Dose Inhaler
Product Code: SCH 032088
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Mometasone
CAS Number: 83919-
Sponsors
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects of any race and either sex and 5 to 11 years of age, inclusive, with a diagnosis of persistent asthma for at least 6 months duration will be eligible for Screening. Subjects must meet all of the inclusion criteria and none of the exclusion criteria to receive treatment assignment. Other key inclusion criteria are as follows: •If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject’s current asthma therapy, the subject (and parent(s)/guardian) must be willing to discontinue their prescribed asthma medication and be transferred to an open-label treatment with MF MDI 50 mcg BID, once all laboratory tests are reviewed, and to one of the study treatments at Baseline. •At both the Screening and Baseline Visits, an FEV1 greater than or equal to 60% and less than or equal to 90% predicted when all restricted medications have been withheld for the appropriate intervals. •A subject must have been treated with a low to medium daily dose of ICS (either alone or in combination with a LABA) for at least 12 weeks and must have been on a stable regimen (daily dose unchanged) for at least 2 weeks before Screening. Low and medium daily doses of ICS are defined as follows: Inhaled corticosteroid Low Daily Dose (mcg) Medium Daily Dose Beclomethasone dipropionate 100-200 >200-400 Budesonide 100-200 >200-400 Budesonide nebs 250-500 >500-1000 Flunisolide 500-750 750-1250 Fluticasone propionate 100-200 >200-500 Triamcinolone acetonide 400-800 >800-1200 Ciclesonide 80-160 >160-320 Mometasone furoate 100 200 a Dose delivery by method or modality other than those noted above must be equivalent. •A subject must have a documented positive beta-2 reversibility test, obtained within the 12 months before the consent/assent form may be signed. Otherwise, to support the diagnosis of asthma and assure the subject's responsiveness to bronchodilators before randomization, the following method must be used at the Screening Visit or at any time prior to the Baseline Visit: oThe subject must demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of 200 mcg to 400 mcg (2 to 4 puffs) of albuterol/salbutamol from a primed MDI or of a nebulized short-acting beta-2 agonist (SABA [2.5 mg]), if confirmed as standard office practice. •Ability to use a peak flow meter correctly and to perform spirometry and PEF measurements. •Clinical laboratory tests (complete blood counts [CBC], blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor prior to starting the run-in treatment. •Demonstration of ability to use MDIs and DPIs correctly using protocol-defined procedures. •Willingness of the subject (and the subject’s legal representative) to give written informed consent/assent and to adhere to dose and visit schedules Are the trial subjects under 18? yes Number of subjects for this age range: 600 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age
Exclusion criteria
Exclusion criteria: • A subject who demonstrates a decrease in absolute FEV1 of greater than 20% at any time from the Screening Visit up to and including the Baseline Visit. • A subject who demonstrates <80% compliance with use of study medication during the 2-week Run-in Period. Compliance will be determined by the number of inhalations recorded by the dose counter at the Baseline Visit (Visit 2). • A subject who requires the use of more than eight inhalations per day of SABA or two or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit. • A subject who has a decrease in AM or PM PEF below the Run-in Period stability limit on any 2 consecutive days prior to randomization. To determine the stability limit, the average AM and average PM PEF respective values from the preceding 7 days will be added, divided by the number of non-missing values, and multiplied by 0.70. • A subject who has an occurrence of clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA as judged by the clinical investigator at any time from the Screening Visit up to and including the Baseline Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the dose-related efficacy by evaluating morning lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second [FEV1]) after 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.;Secondary Objective: (1) To demonstrate the dose-related efficacy of MF MDI BID in improving morning (AM) peak expiratory flow (PEF) when compared with placebo; (2) To assess the dose-related efficacy of MF MDI BID compared with placebo as measured by the Paediatric Asthma Quality of Life Questionnaire with standardised activities (PAQLQ[S]) score; (3) To compare the efficacy of MF MDI 50 mcg BID with that of MF dry powder inhaler (DPI) 100 mcg once a day (QD) in the evening (PM).;Primary end point(s): The primary efficacy variable is the change in percent predicted FEV1 from Baseline to Week 12 for the evaluation of the dose-related efficacy of MF MDI BID, assessing the comparison of MF MDI 50 mcg BID vs. Placebo, MF MDI 100 mcg BID vs. Placebo, and MF MDI 200 mcg BID vs. Placebo. The percent predicted FEV1 equals the subject's observed FEV1 divided by the subject's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%.;Timepoint(s) of evaluation of this end point: Screening, Baseline, weeks 2, 4, 6, 8, and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following additional secondary Efficacy Endpoints will be evaluated for the dose related efficacy of MF MDI BID, as described for the primary efficacy endpoint: (1) Change from Baseline in AM PEF at the 12-week Endpoint (last week of Diary Data). (2) Change from Baseline in Asthma Quality of Life Questionnaire with standardised activities (PAQLQ[S]) score at the 12-week Endpoint (last post-baseline observation carried forward). (3) Compare the efficacy and safety of MF MDI 50 mcg BID to that of the MF dry powder inhaler (DPI) 100 mcg once a day (QD PM) for change from Baseline to 12 Weeks in percent predicted FEV1. ;Timepoint(s) of evaluation of this end point: (1) daily; (2) Baseline, weeks 4, 8, and 12; (3) Screening, Baseline, weeks 2, 4, 6, 8, and 12. | — |
Countries
Bulgaria, Colombia, Croatia, El Salvador, Estonia, Greece, Hungary, India, Latvia, Lithuania, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Switzerland, Turkey, Ukraine, United States
Contacts
Public ContactClinical Monitor
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc.
Outcome results
None listed