EUCTR2020-002036-78-HU进行中（未招募）1 期
An open-label, two-period, single-sequence, crossover study to compare the systemic exposure of a single inhaled dose of mometasone furoate (MF) when administered alone via the MF Twisthaler® (TH) to a single inhaled dose of QMF149 indacaterol acetate/MF fixed dose combination when administered via the Concept 1 (Breezhaler®) device in = 6 to <12 year old asthma patients - Study to compare PK of MF alone & in combination with indacaterol in =6 to <12 years asthma patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
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. Male and female children = 6 years and < 12 years at the time of study entry.
- •2. Written informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.
- •3. Confirmed documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 6 months prior to study
- •enrollment.
- •4. Patients using low dose ICS as asthma controller therapy for at least 4 weeks prior to first treatment.
- •5. Patients who are familiar with the use of an inhaler device.
- •6. Patients must be able to comply with the Study Visit Assessment Schedule which includes approximately 7 hours on two occasions, and
- •agree to blood draws as scheduled.
- •7. Parents/ legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 32
- •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. Use of other investigational drugs within 5 half-lives of enrollment, or [within 30 days (for small molecules) /until the expected pharmacodynamic effect has returned to baseline (for biologics)], whichever is longer.
- •2. Patients with weight < 17kg at screening.
- •3. Patients currently taking MF products for any reason at least 7 days prior to Day 1. Patients can enroll if MF was discontinued at least 7 days prior to Day 1 and MF is substituted with a different steroid during entire study duration to avoid its potential impact on PK assessment. These MF
- •products include inhalation, topical and/or nasal spray formulations.
- •4. Patients on medium- and high- dose ICS or any dose ICS/LABA combination.
- •5. Patients taking maintenance controller therapy (eg LABAs and theophylline) within 4 weeks of screening or during the study. LTRAs are permitted provided that patients have been on a stable dose for 4 weeks prior to screening. Patients using short-acting bronchodilators on occasional basis as rescue medication can enroll, however, these medications must be withheld at least 8 hours prior to study dosing visits and during PK sampling.
- •6. Contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class, or any component there of:
- •Adrenoreceptor agonist agent
- •Lactose or any of the other excipients of the study drug (including patients with history of galactose intolerance, lactase deficiency or glucose-galactose malabsorption)
- •Corticosteroids
- •Indacaterol and/or MF
- •7. History of chronic lung disease other than asthma within 3 months of first treatment visit (Day 1), cystic fibrosis, mycobacterial or other infection (including active SARS-CoV-2, tuberculosis or atypical mycobacterial disease).
- •8. History of active bacterial, viral or fungal infection (including SARS-CoV-2) within 6 weeks of first treatment visit (Day 1).
- •9. Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6
- •weeks of first treatment visit (Day 1).
- •10. Patients who, in the opinion of the investigator, are not able to comply with study treatment or who have any medical or mental disorder, situation, or diagnosis, which could interfere with the proper completion of the study protocol requirements or pose a safety risk while participating in the study.
- •11. Parent/guardian has a history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g. inability to read, comprehend and write) which will limit the validity of consent for their child to participate in this study.
- •12. Hemoglobin levels outside normal ranges at screening.
- •13. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the patient in case of participation in the study.
- •14. Patients who have a clinically significant ECG abnormality or clinically significant abnormal lab values reported at Screening Visit.
- •15. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at Screening Visit (Fridericia method) is prolonged (= 450 msec for males and females 6 - 12 years old).
- •16. Use of any prescription drugs, herbal supplements, prescribed medicinal use of cannabis/marijuana, within four weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements within two weeks pr
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