What is the mechanism of action of this treatment?

The most common treatments for Allergic Bronchopulmonary Aspergillosis (ABPA) include antifungal therapies, corticosteroids, and anti-IgE therapies. Antifungal therapies, like PUR1900, aim to reduce the fungal burden of Aspergillus fumigatus in the lungs, decreasing the antigenic stimulus that drives the allergic response. Corticosteroids reduce inflammation and immune response, helping to control symptoms and prevent lung damage. Anti-IgE therapies, such as omalizumab, bind to IgE antibodies, preventing them from triggering allergic reactions. These treatments are essential for managing symptoms and improving the quality of life for ABPA patients.

What side effects are associated with this type of intervention?

Common treatments for Allergic Bronchopulmonary Aspergillosis (ABPA) include antifungal medications such as voriconazole and itraconazole. Known side effects of these treatments can include liver toxicity, gastrointestinal disturbances (nausea, vomiting, diarrhea), skin rashes, and, in some cases, visual disturbances. Inhaled antifungal treatments like PUR1900 are being studied for their safety and tolerability, with potential side effects including respiratory irritation and fungal resistance. It is important to monitor patients closely for adverse effects during treatment.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments exclusively for Allergic Bronchopulmonary Aspergillosis (ABPA). However, treatments often involve antifungal medications such as itraconazole and corticosteroids to manage inflammation and fungal growth. The trial PUR1900 is investigating an inhaled form of itraconazole, which is an antifungal therapeutic, aiming to improve safety and efficacy in treating ABPA. This approach is similar to existing treatments but focuses on targeted delivery to the lungs.

What other types of research exist?

Promising novel alternatives to PUR1900 for ABPA treatment in 2024 include: 1) Inhaled amphotericin B, which has shown potential in reducing fungal load and inflammation in the lungs. 2) New azole antifungals like isavuconazole, which offer broad-spectrum activity and improved safety profiles. 3) Biologic therapies targeting specific immune pathways involved in ABPA, such as monoclonal antibodies against IL-5 or IL-4/IL-13 pathways, which can help reduce inflammation and allergic responses.

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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

Has a diagnosis of asthma, as per the Global Initiative for Asthma (GINA) 2018 update.

Has a confirmed diagnosis of allergic bronchopulmonary aspergillosis (ABPA), based on specific criteria including a history of or documentation at screening of serum IgE ≥ 500 IU/mL and A. fumigatus-specific IgE>0.35KUA/L, or above normal IgE antibody to A. fumigatus, or a positive immediate skin test and at least 2 of the 3 following supportive criteria: eosinophil count >500 cells/µL; A. fumigatus-specific IgG >27 mgA/L or presence of precipitating (or above normal immunoglobulin G [IgG]) antibody to A. fumigatus; consistent radiographic opacities or bronchiectasis on chest CT.

Must not have

Currently requiring medications that are sensitive substrates for CYP3A4-mediated metabolism or medications that are contraindicated with oral itraconazole.

Has evidence of ventricular dysfunction, such as congestive cardiac failure (New York Heart Association functional class III or IV), or a history of congestive cardiac failure. N-terminal pro B-type natriuretic peptide (NT pro BNP) will be checked at screening only. A subject with a confirmed value of >400 pg/mL will not be eligible to participate.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 168 days

Summary

This trial is testing PUR1900, a medicine you inhale to treat lung infections caused by fungi. It focuses on adults with asthma who also have a fungal lung condition called ABPA. The medicine works by going straight to the lungs to fight the infection. The study will check if PUR1900 is safe and effective for these patients.

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.

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.

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 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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My lung function test shows at least half the normal capacity for someone my age, sex, and height.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on medications that interact with itraconazole.

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I do not have severe heart failure or a history of it, and my NT pro BNP level is below 400 pg/mL.

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I have had a severe asthma attack in the last 2 years that was life-threatening.

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I haven't had a serious infection needing strong medication in the last 28 days.

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I have a hoarse voice or a fungal infection in my mouth.

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I am not pregnant, breastfeeding, or planning to become pregnant, and I have a negative pregnancy test.

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I have no planned surgeries or other studies that could affect this trial.

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I have previously been treated with PUR1900.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 168 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiac safety monitoring

Clinical safety laboratory test results

Incidence of Treatment Emergent Adverse Events (TEAEs)

+3 more

Secondary study objectives

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 study objectives

Fungal resistance to Aspergillus fumigatus

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Allergic Bronchopulmonary Aspergillosis (ABPA) include antifungal therapies, corticosteroids, and anti-IgE therapies. Antifungal therapies, like PUR1900, aim to reduce the fungal burden of Aspergillus fumigatus in the lungs, decreasing the antigenic stimulus that drives the allergic response. Corticosteroids reduce inflammation and immune response, helping to control symptoms and prevent lung damage. Anti-IgE therapies, such as omalizumab, bind to IgE antibodies, preventing them from triggering allergic reactions. These treatments are essential for managing symptoms and improving the quality of life for ABPA patients.

Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.