Allergic Bronchopulmonary Aspergillosis Prescreening Study

NCT05903612 | Withdrawn

• 1 other identifier: 601-0023
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Bronchopulmonary Aspergillosis; Asthma; ABPA

Keywords

ABPA; Allergic Bronchopulmonary Aspergillosis; Asthma

Outcome Measures

Primary Outcomes (2)

• Patients Diagnosed

  Number of patients with known asthma and diagnosis of ABPA

  6 weeks

• Patients Invited

  Number of patients invited to participate in Study 601-0018

  6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be enrolled at study sites in North America, Europe, and the Asia-Pacific region participating in Study 601-0018. Only patients who meet all eligibility criteria will be enrolled in the prescreening study and have blood samples drawn for laboratory testing at the in-clinic visit.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Community Pharmacology Services Ltd: lead
• Pulmatrix Inc.: collaborator

Study Sites (1)

CPS Research

Glasgow, G20 7BE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary; Asthma

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive

Study Officials

• Margaret Wasilewski, MD

  Pulmatrix Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: January 10, 2024
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)