Chronic Pulmonary AspergillosisCAPSULENCT06885905
Impact of Chronic Pulmonary Aspergillosis (CPA) on Health Status and Well-being
An observational study of Chronic Pulmonary Aspergillosis, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
To develop and validate a novel disease-specific questionnaire for measuring HRQoL in patients with Chronic Pulmonary Aspergillosis (CPA-HAQ) for use in clinical research, including clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pulmonary Aspergillosis
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 27 Nov 2024to 23 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Individuals with confirmed Chronic Pulmonary Aspergillosis
Who may be able to join
- All patients >/= 18 years old and able to provide informed consent
- Patients with a diagnosis of chronic pulmonary aspergillosis
- To speak and understand English
- Able to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anand Shah, PhD contact
United Kingdom3 sites, 3 recruiting
- Recruiting
Ninewells Hospital & Medical School
Dundee, DD1 9SY
David Connell, PhD FRCP Edin, david.connell@nhs.scot, david.connell@nhs.scot
David Connell, PhD FRCP Edin
- Recruiting
Imperial College London
London
Dareen Marghlani, MSc, dsm20@ic.ac.uk, dsm20@ic.ac.uk
Anand Shah, PhD
- Recruiting
Manchester NHS Foundation Trust
Manchester
Chris Kosmidis, PhD, chris.kosmidis@manchester.ac.u, chris.kosmidis@manchester.ac.uk
Chris Kosmidis, PhD
About this study
To develop and validate a novel disease-specific questionnaire for measuring HRQoL in patients with Chronic Pulmonary Aspergillosis (CPA-HAQ) for use in clinical research, including clinical trials.
- Conditions
- Chronic Pulmonary Aspergillosis
- Keywords
- CPA
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
To develop and validate a novel disease-specific health-related quality of life (HRQoL) measure in chronic pulmonary aspergillosis (CPA): The Chronic Pulmonary Aspergillosis Health Assessment Questionnaire (CPA-HAQ)
Measured: 30 months
Secondary outcomes (2)
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
Testing the usability of a newly developed CPA-HAQ measure.
Measured: 30 months
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
Correlating how HRQoL outcomes relate to existing disease prognostic markers.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start27 Nov 2024
- Primary completion23 Aug 2025 (estimated)
- Study completion23 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, Tayside Medical Science Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885905
- Sponsor's protocol ID
- 23IC8471
- Acronym
- CAPSULE
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 20 Mar 2025
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Pulmonary Aspergillosis (CPA) on Health Status and Well-being
- ClinicalTrials.gov ID
- NCT06885905
- Acronym / sponsor ID
- CAPSULE / 23IC8471
- Conditions
- Chronic Pulmonary Aspergillosis
- Keywords
- CPA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, Tayside Medical Science Centre
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 23 Aug 2025 (estimated)
- Study completion
- 23 Apr 2026 (estimated)
- First posted
- 20 Mar 2025 (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.
To develop and validate a novel disease-specific questionnaire for measuring HRQoL in patients with Chronic Pulmonary Aspergillosis (CPA-HAQ) for use in clinical research, including clinical trials.
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
- Individuals with confirmed Chronic Pulmonary Aspergillosis
Key inclusion criteria (4 listed)
- All patients >/= 18 years old and able to provide informed consent
- Patients with a diagnosis of chronic pulmonary aspergillosis
- To speak and understand English
- Able to provide informed consent
Key exclusion criteria (0 listed)
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
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
Time frame: 30 months
To develop and validate a novel disease-specific health-related quality of life (HRQoL) measure in chronic pulmonary aspergillosis (CPA): The Chronic Pulmonary Aspergillosis Health Assessment Questionnaire (CPA-HAQ)
2 secondary outcomes
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
Time frame: 30 months
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- NHS Health Research AuthorityLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Pulmonary Aspergillosis
Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
RecruitingPhase 3
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis, CPA
Not yet recruitingPhase 1
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
Chronic Pulmonary Aspergillosis
Active, not recruitingPhase 2
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Chronic Pulmonary Aspergillosis, Aspergillosis
Active, not recruitingPhase 2
Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options
Chronic Pulmonary Aspergillosis
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.
Anand Shah, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pulmonary Aspergillosis, run by Imperial College London at 3 sites 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 4 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dareen Marghlani, MSc (dsm20@ic.ac.uk, dsm20@ic.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being. (time frame: 30 months). 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 20 Mar 2025.