Pediatric Dose-Ranging of Mometasone Furoate MDI

• Conditions: Asthma; MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2008-007504-28-GR
• Lead Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-28
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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 acetonide400-800 >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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified