Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05903612




Registration number
NCT05903612
Ethics application status
Date submitted
6/06/2023
Date registered
15/06/2023
Date last updated
30/08/2023

Titles & IDs
Public title
Allergic Bronchopulmonary Aspergillosis Prescreening Study
Scientific title
A Prescreening Study to Diagnose Allergic Bronchopulmonary Aspergillosis in Selected Patients With Asthma
Secondary ID [1] 0 0
601-0023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Bronchopulmonary Aspergillosis 0 0
Asthma 0 0
ABPA 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Allergies
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patients Diagnosed
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Patients Invited
Timepoint [2] 0 0
6 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Other
Name
Community Pharmacology Services Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pulmatrix Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05903612
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Margaret Wasilewski, MD
Address 0 0
Pulmatrix Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rory Taylor
Address 0 0
Country 0 0
Phone 0 0
0141 946 7888
Fax 0 0
Email 0 0
rory.taylor@cpsresearch.co.uk
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05903612