EUCTR2009-010110-30-DK进行中（未招募）1 期
A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate / Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared with Mometasone Furoate (MF, MK-0887 [SCH032088]), in Children with Persistent Asthma - MK-0887A efficacy and long-term safety in children with persistent asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •1.Be willing to give written informed consent/assent (in accordance with local regulations) prior to Screening; and the subject’s legal representative must also give written informed consent for the subject to participate in the trial. The subject’s legal representative may also provide written informed consent and the subject provide assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •For the PK Sub-trial: subject and the subject’s legal representative must be willing to actively participate in the main trial and indicate understanding and willingness to participate in the sub-trial by signing the sub-trial specific informed consent/assent.
- •2.Be between 5 and 11 years of age (inclusive) at Visit 1, of either sex, and of any race.
- •3.Have a diagnosis of asthma according to the international guidelines of at least 6 months prior to Visit 1 (Global Initiative for Asthma [GINA] Guidelines Available from: http://www.ginasthma.org/).
- •4.Have asthma that is adequately controlled on a stable dose of ICS/LABA combination therapy for at least 4 weeks prior to Visit 1 according to the clinical judgment of the investigator.
- •5.Demonstrate at Visit 1, an FEV1 >60% and =90% predicted when all restricted medications have been withheld for the appropriate intervals.
- •6.Demonstrate at Visit 1, an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol/salbutamol (must be demonstrated according to the procedure specifically defined in Appendix 12.8). If the 12% reversibility criterion is not met at Visit 1, reversibility must be demonstrated prior to the randomization visit (Visit 3).
- •7.Demonstrate an ability to follow trial procedures (including use of MDI training inhaler, use of open-label run-in medication, use of PEF meter, and use of eDiary [IVRS/IWRS]) to the satisfaction of the investigator/qualified designee prior to randomization.
- •8.Have clinical laboratory tests (complete blood count [CBC], blood chemistries, including urine pregnancy for female subjects of child-bearing potential [i.e., who have started menstruating], and urinalysis) conducted at Visit 1 documented to be clinically acceptable to the investigator before beginning the Run-in Period. A female subject of childbearing potential (i.e., who has started menstruating) must have a negative urine pregnancy test at Visit 1 to be considered eligible for the trial.
- •9. Demonstrate the ability to: use an MDI (without spacer) correctly according to protocol-defined procedures at Visit 1 (Screening Visit) and Visit 2 (Run-in Visit); use a peak flow meter correctly and perform spirometry correctly before Visit 2 (Run-in Visit).
- •10. Be willing (with consent of their parent(s)/guardian [i.e., caregiver]) to discontinue his/her prescribed asthma medication before beginning the Run-in Period, if based upon the medical judgment of the investigator, there is no inherent harm in changing the subject’s current asthma therapy.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 160
- •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 range
排除标准
- •1.Requires the use of >8 inhalations per day of albuterol, 100 mcg per actuation (or its equivalent), and/or >2 nebulized treatments per day of 2.5 mg albuterol (or its equivalent), on any 2 consecutive days between the Screening Visit (Visit 1) and the Randomization Visit (Visit 3). If a subject uses both MDI and nebulized formulations of SABA in the same day, then one nebulized treatment is considered equivalent to 4 inhalations of the MDI in order to calculate if the subject has exceeded the equivalent of 8 inhalations in total SABA use for that day.
- •2.Experiences a clinical worsening of asthma between the Screening Visit (Visit 1) and the Randomization Visit (Visit 3), that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA).
- •3.Has experienced an upper or lower respiratory tract infection within the 4 weeks prior to Visit 1. If there is evidence of an upper or lower respiratory tract infection at Visit 1 or at Visit 2 (prior to the subject entering the Run-in Period), the subject may be treated as appropriate, and Visit 1 or Visit 2 can be rescheduled to be at least 4 weeks after resolution.
- •4.Demonstrates <80% compliance with use of trial medication during the 2 week Run-in Period. Compliance will be determined prior to randomization at Visit 3 and will be determined by comparing the change in dose counter readings relative to the duration of treatment as entered on the eCRF.
- •5.Is considered to have unstable asthma at the end-of the Run-in Period, based on the clinical judgment of the investigator.
- •6.Has had greater than 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or a 24-hour or longer stay in an emergency department, urgent care center, and/or hospital) within the 52 weeks prior to Visit 1.
- •7.Has been taking any restricted medications prior to the Screening Visit (Visit 1) without meeting the required washout timeframes.
- •8.Has a known or suspected hypersensitivity to ICS, beta2 agonists, or any components of the trial medications.
- •9. Has had a history of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support.
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