EUCTR2018-002949-11-GB进行中（未招募）1 期
A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis - Phase 2 study to evaluate PUR1900 in asthmatic patients with ABPA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
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
- •Participants must meet all of the following criteria to be enrolled into this study:
- •1.Can provide written informed consent before the performance of any study-specific procedures.
- •2.Is a male or female, 18 to 75 years old (inclusive) at the time of signing the informed consent.
- •3.Has a body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
- •4.Has a historical diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update (Section 13.1).
- •5.Has a confirmed historical diagnosis of ABPA, as per the Modified International Society for Human and Animal Mycology (ISHAM) working group 2013 criteria (Section 13.2).
- •6.Is currently considered to be in one of the following stages of ABPA: Stage 2 (Response), Stage 4 (Remission), Stage 5a (Treatment-dependent ABPA), or Stage 5b (Glucocorticoid-dependent asthma) (Section 13.3).
- •7.Has a serum immunoglobulin (Ig) E =1000 IU/mL during screening (Visit 1 or Visit 2).
- •8.Can perform a valid, reproducible spirometry test with demonstration of a prebronchodilator FEV1 =50% of predicted normal for age, sex, race, and height (Quanjer et al 2012) at a screening visit.
- •9.Has a documented stable asthma medication regimen during screening (Day 28 to Day 1), including SABA, LABA, and LTRA use and inhaled and/or oral GCS.
- •10.Subjects who are sexually active, male subjects able to father a child, and female subjects of childbearing potential must agree to follow the contraception requirements outlined in Section 5.8.4 of this protocol.
- •11.Can demonstrate the correct inhalation technique for the use of the delivery device at screening and before dosing on Day 1.
- •12.Is willing and able to comply with all study procedures and assessments, including scheduled visits, drug dosing plan, study procedures, laboratory tests, and study restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •A participant who meets any of the following criteria will be excluded from the study:
- •1.Has used any anti-IgE (eg, Xolair® [omalizumab]) or anti-interleukin-5 (IL-5) biologics (eg, Cinqair® [reslizumab], Nucala® [mepolizumab], or Fasenra® [benralizumab]) in the 6 months before first dose of study drug.
- •2.Is a female of childbearing potential who is pregnant or lactating or who plans to become pregnant during the study (all female subjects must have a negative pregnancy test at screening and predose on Day 1). A woman is considered to be of childbearing potential unless she is either permanently sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal occlusion/ligation) or postmenopausal (had no menses for 12 months without an alternative medical cause).
- •3.Is taking or has taken any prescribed or over-the-counter (OTC) drug that is a CYP3A4 inhibitor or substrate in the 14 days (or 5 half-lives, whichever is longer) before first dose of study drug and for the duration of the study (Section 13.4) (exclusion also applies to the whole fruit or juices of grapefruit and Seville or pomelo oranges).
- •4.Is taking or has taken any herbal remedies or CYP3A4 inducers in the 28 days before first dose of study drug (Section 13.4).
- •5.Has used any systemic azole antifungal agent in the 6 months before first dose of study drug.
- •6.Has a history of life-threatening asthma within the last 5 years, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, and/or hypoxic seizures.
- •7.Had an occurrence of asthma or ABPA exacerbations (as defined in Section 13.5) within the 28 days before screening or during the 28-day period before Day 1.
- •8.Had an occurrence of clinically significant bacterial, viral, or fungal infection that required systemic (oral or intravenous) antibiotics, antivirals, or antifungals within the 28 days before screening. Topical treatments, other than antifungals, are allowed.
- •9.Received any investigational medical product in a clinical research study within the previous 3 months before dosing in this study.
- •10.Is a study site employee, an immediate family member of a study site employee, or a sponsor employee.
- •11.Has previously received PUR1900.
- •12.Has a history of any significant drug or alcohol abuse in the past 2 years before screening, as judged by the investigator.
- •13.Has current tobacco or inhaled marijuana use or history of smoking tobacco or marijuana within the last 6 months before screening.
- •14.Is a current user of e-cigarettes or has used these products within the last 6 months before screening.
- •15.Has the absence of suitable veins for multiple venipunctures/cannulation as assessed by the investigator or designee at screening.
- •16.Has evidence or history of clinically significant abnormal serum chemistry, hematology, or urinalysis at screening, as judged by the investigator (particularly elevation of liver enzymes or bilirubin).
- •17.Has a positive urine test result for drugs of abuse, alcohol, or cotinine at screening (unless, in the opinion of the investigator, this can be explained by the subject’s current medications).
- •18.Has a positive human immunodeficiency virus (HIV; type A and type B) antibody result: a subject who is HIV antibody positive is not excluded if a subsequent CD4 count is =200 cells/µL.
- •19.Has evidence or a history of clinically significant cardiovascular, renal, hepatic, or gastrointestinal disease or neurological or
研究者
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