EUCTR2008-007504-28-EE进行中（未招募）不适用
12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in theTreatment of Children Ages 5 to 11 Years With Persistent Asthma - Pediatric Dose-Ranging of Mometasone Furoate MDI
Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co., Inc0 个研究点目标入组 600 人开始时间: 2012年1月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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