Allergic Bronchopulmonary Aspergillosis Prescreening Study (NCT05903612) | Clinical Trial Compass
WithdrawnNot Applicable
Allergic Bronchopulmonary Aspergillosis Prescreening Study
Stopped: Reasons unrelated to safety issues
United Kingdom0Started 2024-01-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✓. 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.
✓. 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).