Allergic Bronchopulmonary Aspergillosis Prescreening Study

Sponsor

Community Pharmacology Services Ltd (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05903612

Collaborator

Pulmatrix Inc. (Industry)

100

Enrollment

Location

Anticipated Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Bronchopulmonary Aspergillosis Asthma ABPA

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Outcome Measures

Primary Outcome Measures

Patients Diagnosed [6 weeks]
Number of patients with known asthma and diagnosis of ABPA
Patients Invited [6 weeks]
Number of patients invited to participate in Study 601-0018

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provide written informed consent before the performance of any study-specific procedures at the in-clinic visit.
Is a male or female ≥18 years old.
Has a BMI of ≥18.0 and <40.0 kg/m2 at the in-clinic visit.
Meets the following criteria:
Has a diagnosis of asthma.
At least 1 exacerbation requiring a systemic glucocorticosteroid(s) or hospital admission in the last 10 months.
Is willing and able to comply with all study procedures

Exclusion Criteria:

Has used omalizumab (Xolair®) in the 11 months prior to screening or plans to use omalizumab during the study.
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.
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).
Smoking marijuana or tobacco, the use of e-cigarettes, vaping, or any other smoking is prohibited during the study.