Allergic Bronchopulmonary AspergillosisNCT05903612
Allergic Bronchopulmonary Aspergillosis Prescreening Study
An observational study of Allergic Bronchopulmonary Aspergillosis and Asthma, run by Community Pharmacology Services Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Bronchopulmonary Aspergillosis, Asthma, ABPA
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2024to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Bronchopulmonary Aspergillosis, Asthma, ABPA
- Keywords
- ABPA, Allergic Bronchopulmonary Aspergillosis, Asthma
- Medical subject headings
- Aspergillosis, Allergic Bronchopulmonary, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Diagnosed
Number of patients with known asthma and diagnosis of ABPA
Measured: 6 weeks
Patients Invited
Number of patients invited to participate in Study 601-0018
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start10 Jan 2024
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Why it stopped: Reasons unrelated to safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Bronchopulmonary AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community Pharmacology Services Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Pulmatrix Inc.
- Responsible party
- Sponsor
- Investigators
- Margaret Wasilewski, MD, Study director, Pulmatrix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903612
- Sponsor's protocol ID
- 601-0023
- Status last verified
- Jan 2024
- First submitted
- 6 Jun 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prescreening Study to Diagnose Allergic Bronchopulmonary Aspergillosis in Selected Patients With Asthma
- ClinicalTrials.gov ID
- NCT05903612
- Acronym / sponsor ID
- 601-0023
- Conditions
- Allergic Bronchopulmonary Aspergillosis, Asthma, ABPA
- Keywords
- ABPA, Allergic Bronchopulmonary Aspergillosis, Asthma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Reasons unrelated to safety issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Community Pharmacology Services LtdUniversity, hospital or other
- Collaborators
- Pulmatrix Inc.
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- Is willing and able to comply with all study procedures
Key exclusion criteria (5 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients Diagnosed
Time frame: 6 weeks
Number of patients with known asthma and diagnosis of ABPA
Patients Invited
Time frame: 6 weeks
Number of patients invited to participate in Study 601-0018
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Wasilewski, MD study director
Pulmatrix Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Bronchopulmonary Aspergillosis and Asthma, run by Community Pharmacology Services Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Diagnosed (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.