Impact of Chronic Pulmonary Aspergillosis (CPA) on Health Status and Well-being (CAPSULE)

March 13, 2025 updated by: Imperial College London
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dareen Marghlani, MSc
  • Phone Number: dsm20@ic.ac.uk
  • Email: dsm20@ic.ac.uk

Study Contact Backup

Study Locations

  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Recruiting
        • Ninewells Hospital & Medical School
        • Contact:
        • Principal Investigator:
          • David Connell, PhD FRCP Edin
      • London, United Kingdom
        • Recruiting
        • Imperial College London
        • Contact:
          • Dareen Marghlani, MSc
          • Phone Number: dsm20@ic.ac.uk
          • Email: dsm20@ic.ac.uk
        • Principal Investigator:
          • Anand Shah, PhD
      • Manchester, United Kingdom
        • Recruiting
        • Manchester NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Chris Kosmidis, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with confirmed Chronic Pulmonary Aspergillosis

Description

Inclusion Criteria:

  1. All patients >/= 18 years old and able to provide informed consent
  2. Patients with a diagnosis of chronic pulmonary aspergillosis
  3. To speak and understand English
  4. Able to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
Time Frame: 30 months
Testing the usability of a newly developed CPA-HAQ measure.
30 months
Impact of Chronic Pulmonary Aspergillosis (CPA) on health status and Well-being.
Time Frame: 30 months
Correlating how HRQoL outcomes relate to existing disease prognostic markers.
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Manchester University NHS Foundation Trust
Tayside Medical Science Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2024

Primary Completion (Estimated)

August 23, 2025

Study Completion (Estimated)

April 23, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23IC8471

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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