A randomized, phase 2 study to evaluate Safety, Tolerability and pharmacokinetics of Itraconazole as Dry Powder for Inhalation in adult Asthmatic Patients
- Conditions
- Health Condition 1: B441- Other pulmonary aspergillosis
- Registration Number
- CTRI/2019/08/020764
- Lead Sponsor
- Pulmatrix Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
5. Has a confirmed historical diagnosis of ABPA, as per the Modified International Society for Human and Animal Mycology (ISHAM) working group 2013 criteria.
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 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.
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 (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.
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Primary outcome to evaluate safety and tolerability will be measured by: <br/ ><br>• Incidence of treatment-emergent adverse <br/ ><br>events <br/ ><br>• Incidence of intraday FEV1 declines (from predose to postdose) of =10%, =15%, and =20% <br/ ><br>• Vital sign measurements (respiratory rate, <br/ ><br>blood pressure, heart rate, oxygen saturation <br/ ><br>by pulse oximetry, oral or tympanic <br/ ><br>temperature) <br/ ><br>• Physical examination findings <br/ ><br>• Clinical laboratory parameters <br/ ><br>• 12-Lead electrocardiogram findingsTimepoint: Time Frame: From Day 1 through Follow Up (which is 7 to 10 days after the last dose)
- Secondary Outcome Measures
Name Time Method