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Antifungal

Inhaled Itraconazole for Allergic Bronchopulmonary Aspergillosis

Phase 2
Waitlist Available
Research Sponsored by Pulmatrix Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is a male or female, ≥18 years old at the time of signing the informed consent.
Has a diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 168 days
Awards & highlights

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.

Who is the study for?
Adults over 18 with asthma and ABPA who can perform a spirometry test, have an FEV1 ≥50% of predicted normal, and demonstrate correct inhalation technique. They must not be pregnant or planning pregnancy, agree to contraception if applicable, and have stable asthma medication use. Excluded are those with severe liver issues, recent serious infections or surgeries, certain heart conditions, recent azole antifungal use, or history of significant drug/alcohol abuse.Check my eligibility
What is being tested?
The trial is testing PUR1900 (Itraconazole Powder) as an inhaled treatment for ABPA in asthmatic patients. It will assess safety/tolerance and the effect on ABPA symptoms over a period including a screening phase (28 days), treatment phase (112 days), and observation phase (56 days). Participants will also record daily health diaries.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Itraconazole or other ingredients in the powder form. Since it's an antifungal medication delivered by inhalation, there could also be respiratory side effects like coughing or wheezing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years or older.
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I have been diagnosed with asthma according to the GINA 2018 guidelines.
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I have been diagnosed with ABPA based on specific tests and criteria.
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My ABPA is in stage 2, 4, 5a, or 5b.
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I've needed steroids for an asthma flare-up in the last year.
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My asthma medication has been the same for the last 28 days.
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My lung function test shows at least half the normal capacity for someone my age, sex, and height.
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I am willing and able to follow all study requirements.
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I agree to use birth control if I can have children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~168 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiac safety monitoring
Clinical safety laboratory test results
Incidence of Treatment Emergent Adverse Events (TEAEs)
+3 more
Secondary outcome measures
Frequency of asthma exacerbations versus baseline
Magnitude of effect of daily administration of PUR1900 - Patient Reported Outcomes (ACQ)
Magnitude of effect of daily administration of PUR1900 - Patient Reported Outcomes (AQLQ(s) 12+)
+1 more
Other outcome measures
Fungal resistance to Aspergillus fumigatus

Side effects data

From 2022 Phase 4 trial • 17 Patients • NCT04035187
14%
Headache
7%
Fatigue
7%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fast Tablet
Oral Solution
Medium Tablet
Slow Tablet

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PUR1900 40 mgExperimental Treatment1 Intervention
4 PUR1900 (10 mg itraconazole) Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day.
Group II: PUR1900 20 mgExperimental Treatment1 Intervention
2 PUR1900 (10 mg itraconazole) Capsules with 20 mg total powder (10 mg itraconazole plus 10 mg excipients) and 2 Placebo Capsules with with 11.8 mg total powder (excipients only) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day.
Group III: PlaceboPlacebo Group1 Intervention
4 Placebo Capsules with with 11.8 mg total powder (excipients only) administered via oral inhalation, using the RS01 Monodose inhaler once daily for 112 days at approximately the same time each day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole Powder
2018
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Pulmatrix Inc.Lead Sponsor
15 Previous Clinical Trials
406 Total Patients Enrolled
2 Trials studying Allergic Bronchopulmonary Aspergillosis
7 Patients Enrolled for Allergic Bronchopulmonary Aspergillosis
Margaret Wasilewski, MDStudy DirectorPulmatrix Inc.
1 Previous Clinical Trials
1 Trials studying Allergic Bronchopulmonary Aspergillosis

Media Library

Itraconazole (Antifungal) Clinical Trial Eligibility Overview. Trial Name: NCT05667662 — Phase 2
Allergic Bronchopulmonary Aspergillosis Research Study Groups: Placebo, PUR1900 40 mg, PUR1900 20 mg
Allergic Bronchopulmonary Aspergillosis Clinical Trial 2023: Itraconazole Highlights & Side Effects. Trial Name: NCT05667662 — Phase 2
Itraconazole (Antifungal) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05667662 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~4 spots leftby Mar 2025