Allergic Bronchopulmonary Aspergillosis Prescreening Study

NCT ID: NCT05903612

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2024-01-10

Brief 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.

Detailed 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.

Conditions

Allergic Bronchopulmonary Aspergillosis; Asthma; ABPA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmatrix Inc.

INDUSTRY

Sponsor Role: collaborator

Community Pharmacology Services Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Wasilewski, MD

Role: STUDY_DIRECTOR

Pulmatrix Inc.

Locations

CPS Research

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

601-0023

Identifier Type: -

Identifier Source: org_study_id