The goal of this clinical trial is to learn about PUR1900 as an inhaled, antifungal therapeutic for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. The main questions it aims to answer are: 1. Is PUR1900 safe and well tolerated in adults with asthma and ABPA? 2. Is there an effect of daily administration of PUR1900 on potential outcome measures in adults with asthma and ABPA? 3. Is there fungal resistance to A. fumigatus? This study includes a 28-day screening period, a 112-day (16-week) treatment period, and a 56-day (8 week) observation period. Participants will take either 40mg of PUR1900, 20 mg of PUR1900 or Placebo for 112 days and complete an eDairy, answer questions about their asthma and complete peak respiratory flow measurements at home. They will come to the clinic approximate once a month during the treatment period and complete study assessments. At the end of the observation period participants will complete one more clinic visit. Participants who complete this study may be given the opportunity to continue on study drug in an open label extension study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients)
Capsules with 11.8 mg total powder (excipients only)
University of Alabama Medical Center at Birmingham
Birmingham, Alabama, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
Jonathan Corren, MD
Santa Monica, California, United States
Bensch Clinical Research
Stockton, California, United States
Southern Illinois University Center for Clinical Research
Springfield, Illinois, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Baylor University Medical Center
Dallas, Texas, United States
UTMB Health
Galveston, Texas, United States
Westmead Hospital
Westmead, New South Wales, Australia
Mater Hospital Brisbane, Respiratory Research Group
South Brisbane, Queensland, Australia
...and 8 more locations
Incidence of Treatment Emergent Adverse Events (TEAEs)
Review of TEAEs from time of consent to study completion.
Time frame: 168 days
Safety spirometry assessments
FEV1 (the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration), FVC (liters), and PEFR (L/min) measurements compared to baseline.
Time frame: 168 days
Vital sign measurements
Vital signs measurements collected before exposure, during and after treatment and compared to baseline. Vital sign measurements will include respiratory rate (bpm), blood pressure (mmHg), heart rate (bpm), oxygen saturation (by pulse oximetry), and oral or tympanic temperature (°C).
Time frame: 168 days
Physical examinations
At screening, a complete physical examination will be performed which includes measurement of height (cm), weight (kg) and evaluation of appearance; skin; head and neck; eyes, ears, nose, and throat; chest and lungs; heart; abdomen; neurological system; and extremities.
Time frame: 168 Days
Clinical safety laboratory test results
Hematology, serum chemistry, or urinalysis test results (normal, abnormal, clinical significance) compared to baseline.
Time frame: 168 days
Cardiac safety monitoring
Electrocardiogram (ECG) recordings collected before exposure, during and after treatment. Electrocardiogram measurements will include heart rate and PR, RR, QRS, and QT intervals, as well as the QTcF and compared to baseline.
Time frame: 168 days
Magnitude of effect of daily administration of PUR1900 - Spirometry
Changes in measured Forced Expiratory Volume (FEV1) over time compared to baseline
Time frame: 168 days
Magnitude of effect of daily administration of PUR1900 - Patient Reported Outcomes (ACQ)
Responses to the Asthma Control Questionnaire (ACQ) sored from 0-6 with 0 being totally controlled and 6 being extremely poorly controlled compared to baseline.
Time frame: 168 days
Magnitude of effect of daily administration of PUR1900 - Patient Reported Outcomes (AQLQ(s) 12+)
Responses to the Asthma Quality of Life Questionnaire with scores ranging 1-7 and higher scores indicating better quality of life compared to baseline.
Time frame: 168 days
Frequency of asthma exacerbations versus baseline
Occurrence of asthma exacerbations before, during, and after treatment with PUR1900
Time frame: 168 days
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