Allergic Bronchopulmonary Aspergillosis Prescreening Study
Megadott ok: Reasons unrelated to safety issues
Key facts
- Where
- Glasgow, Egyesült KirályságSee the site
Where in Egyesült Királyság
- CPS ResearchGlasgow, Egyesült KirályságNo longer taking part
Trial details
- Who runs it
- Community Pharmacology Services Ltd
- Trial code
- NCT05903612
- Record updated
- 2024. január 16.
- Original description
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.Read full original descriptionShow less
A Prescreening Study to Diagnose Allergic Bronchopulmonary Aspergillosis in Selected Patients With Asthma
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.
Inclusion: 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: Has used omalizumab (Xolair®) in the 11 months prior to screening or plans to use omalizumab during the study; 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); 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; Smoking marijuana or tobacco, the use of e-cigarettes, vaping, or any other smoking is prohibited during the study; -.