Allergic Bronchopulmonary Aspergillosis Prescreening Study

Withdrawn

• Conditions: Asthma; Allergic Bronchopulmonary Aspergillosis; ABPA

• Registration Number: NCT05903612
• Lead Sponsor: Community Pharmacology Services Ltd

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.

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Status Verified: 2024-01
• Study Start: 2024-01-10
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

CPS Research; 🇬🇧 Glasgow, United Kingdom