Allergic Bronchopulmonary Aspergillosis Prescreening Study

Asthma Clinical Trial

Official title:

A Prescreening Study to Diagnose Allergic Bronchopulmonary Aspergillosis in Selected Patients With Asthma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05903612
• Other study ID #: 601-0023
• Status: Withdrawn
• Start date: January 10, 2024
• Est. completion date: January 10, 2024

Study information

• Verified date: January 2024
• Source: Community Pharmacology Services Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prescreening study is being conducted to diagnose ABPA in selected patients with asthma and to increase the potential number of eligible participants for the ongoing Study 601-0018 of PUR1900 in subjects with ABPA. See: NCT05667662.

Additionally, this prescreening study may provide information that could assist the conduct of future studies conducted by Pulmatrix.

Description:

See NCT05667662 for a detailed description fo the main ABPA study. This prescreening study is designed to diagnose ABPA in patients with asthma to potentially increase the number of eligible participants for the ongoing NCT05667662 study. This diagnosis will be confirmed through chest x-rays and a blood sample.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provide written informed consent before the performance of any study-specific procedures at the in-clinic visit.

2. Is a male or female =18 years old.

3. Has a BMI of =18.0 and <40.0 kg/m2 at the in-clinic visit.

4. Meets the following criteria:

1. Has a diagnosis of asthma.

2. At least 1 exacerbation requiring a systemic glucocorticosteroid(s) or hospital admission in the last 10 months.

3. For patients on a biologic agent, at least one exacerbation requiring a systemic glucocorticosteroid(s) or hospital admission must have occurred at least 3 months after the initiation of the biologic agent.

5. Is willing and able to comply with all study procedures

Exclusion Criteria:

1. Has used omalizumab (Xolair®) in the 11 months prior to screening or plans to use omalizumab during the study.

2. Has a current diagnosis of any chronic airway disease other than asthma, ABPA, or bronchiectasis believed to be related to ABPA, such as chronic obstructive pulmonary disease, pulmonary fibrosis, CF, or Churg-Strauss syndrome.

3. Currently requiring medications that are sensitive substrates for CYP3A4-mediated metabolism or medications that are contraindicated during and 2 weeks after treatment with oral formulations of itraconazole without the possibility of washout (See Appendix 4).

4. Smoking marijuana or tobacco, the use of e-cigarettes, vaping, or any other smoking is prohibited during the study.

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Related Conditions & MeSH terms

• ABPA
• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Asthma
• Pulmonary Aspergillosis

Locations

Country	Name	City	State
United Kingdom	CPS Research	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Community Pharmacology Services Ltd	Pulmatrix Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Diagnosed	Number of patients with known asthma and diagnosis of ABPA	6 weeks
Primary	Patients Invited	Number of patients invited to participate in Study 601-0018	6 weeks