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Inhaled Itraconazole for Allergic Bronchopulmonary Aspergillosis
Study Summary
This trial is researching a new inhaled antifungal drug to treat allergic bronchopulmonary aspergillosis (ABPA) in those with asthma. Participants take the drug or placebo for 112 days and complete study assessments. Those who complete will be eligible to continue the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 17 Patients • NCT04035187Trial Design
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- I haven't had a serious infection needing strong medication in the last 28 days.I have been diagnosed with ABPA based on specific tests and criteria.I agree to use birth control if I can have children.My asthma medication has been the same for the last 28 days.I am willing and able to follow all study requirements.I have no planned surgeries or other studies that could affect this trial.I do not have severe heart failure or a history of it, and my NT pro BNP level is below 400 pg/mL.You had a bad reaction to itraconazole or other similar antifungal medicines in the past.Your liver enzymes (ALT or AST) are more than twice the normal limit, your white blood cell count is very high, your absolute neutrophil count is very low, or your platelet counts are too low or too high.I have been diagnosed with asthma according to the GINA 2018 guidelines.My lung function test shows at least half the normal capacity for someone my age, sex, and height.My ABPA is in stage 2, 4, 5a, or 5b.I have a chronic lung condition other than asthma or ABPA.I am not pregnant, breastfeeding, or planning to become pregnant, and I have a negative pregnancy test.I stopped taking any biological treatments 3 months ago.I have not taken any systemic antifungal medication in the last 6 weeks.I am not on medications that interact with itraconazole.Your heart's electrical activity, measured by an ECG, shows a prolonged QT interval.I am 18 years or older.I have had a severe asthma attack in the last 2 years that was life-threatening.Your blood test shows high levels of a substance called IgE.I had an asthma attack or ABPA flare-up in the last 28 days.I have a hoarse voice or a fungal infection in my mouth.I have not had major surgery or serious injury in the last 28 days.I do not have any major health issues that could affect my safety in the study.I have smoked or vaped tobacco or marijuana in the past 6 months.Your body mass index (BMI) is between 18 and 40.I have previously been treated with PUR1900.I've needed steroids for an asthma flare-up in the last year.Your urine test shows that you have been using illegal drugs or nicotine, unless it's from medications you're taking or legal tobacco/nicotine products.
- Group 1: Placebo
- Group 2: PUR1900 40 mg
- Group 3: PUR1900 20 mg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are individuals under the age of 65 capable of participating in this research?
"The enrolment requirements of this clinical trial stipulate that the minimum age must be 18 while the maximum is 80."
Are there any vacancies left for participants in this clinical research?
"Present on clinicaltrials.gov, this medical trial is actively enrolling participants with a first posting date of December 1st 2022 and last edited as recently as the 19th of December in the same year."
Is PUR1900 40 mg sanctioned by the FDA?
"Our team at Power believes that PUR1900 40 mg receives a safety rating of 2, as the medication is still in Phase 2 trials and has not yet been proven effective. However, there have already been some studies supporting its safety profile."
What is the total sample size for this research endeavor?
"Affirmative. The information hosted on clinicaltrials.gov signals that this medical trial, which was first announced on December 1st 2022, is actively searching for recruits. Approximately 30 patients need to be enlisted from a single center of care."
What are the fundamental goals of this exploration?
"The main objective of this 168 day trial, sponsored by Pulmatrix Inc., is to measure patient safety through spirometry assessments. Secondary outcomes being monitored include the magnitude of effect on daily administration for Patient Reported Outcomes (ACQ), Asthma Quality of Life Questionnaire scores (AQLQ(s) 12+), and asthma exacerbation frequency compared to baseline values."
To whom is this research opportunity available?
"This research trial is searching for 30 participants aged 18-80 years old who have allergic bronchopulmonary aspergillosis. Qualified applicants must be either male or female, with a body mass index between 18 and 40 kg/m2, an IgE antibody level of at least 1000 IU/mL, proof of at least one exacerbation in the last 12 months that necessitated oral steroids, FEV1 above 50% predicted normal per person's age, sex, race and height ,and demonstrate correct inhaler technique. Additionally they must meet criteria set out by Global Initiative for Asthma (GINA) 2018 update"
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