Paediatric BronchiectasisCASTLENCT07728006
The Development of Paediatric Bronchiectasis Quality of Life Questionnaires for Four Demographic Groups: Children 8-12years, Young People 13 - 17 Years and Parent Proxy Versions for Ages 2-5years and 6-12years
An observational study of Paediatric Bronchiectasis, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To develop and refine a disease-specific quality of life (QoL) questionnaire for children with bronchiectasis, informed by qualitative interviews with affected children, young people, and their parents. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Paediatric Bronchiectasis
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2026to 30 Sep 2027
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 2years to 17 years with a CT diagnosis of Paediatric Bronchiectasis -unrelated to CF or PCD. Also parents of children and young people aged 2years-12years with a CT diagnosis of Paediatric Bronchiectasis -unrelated to CF or PCD.
Who may be able to join
- Patient, child and young persons, aged 8 -17 years with bronchiectasis diagnosed on CT scan
- Parent of child aged 2-12 years with bronchiectasis diagnosed on CT scan
- Written informed consent/assent available
Who cannot join
- Child under 8 years with bronchiectasis for patient direct participation
- No consent/assent received
- Confirmed Cystic Fibrosis or Primary Ciliary Dyskinesia diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Birmingham Womens and Childrens NHS Foundation Trust
Birmingham, B4 6NH
About this study
Official title: The Development of Paediatric Bronchiectasis Quality of Life Questionnaires
To develop and refine a disease-specific quality of life (QoL) questionnaire for children with bronchiectasis, informed by qualitative interviews with affected children, young people, and their parents.
The paediatric bronchiectasis- specific quality of life (PQOL-B) questionnaire will be developed across four demographics:
Children aged 8-12 years
Young people aged 13 -17 years
Parent-proxy for 2-5years
Parent-proxy for 6-12years
Read the detailed description
To develop and refine a disease-specific quality of life (QoL) questionnaire for children with bronchiectasis, informed by qualitative interviews with affected children, young people, and their parents.
The paediatric bronchiectasis- specific quality of life (PQOL-B) questionnaire will be developed across four demographics:
- Children aged 8-12 years
- Young people aged 13 -17 years
- Parent-proxy for 2-5years
- Parent-proxy for 6-12years
The development of the questionnaires will be carried out by conducting two different stages of interviews over a 12- month time period:
- Concept Elicitation - Semi structured interviews - will be to talk about what life is like living with bronchiectasis or living with a child who has bronchiectasis.
- Cognitive testing interviews - Once investigators create a first draft of the PQOL-B questionnaire, investigators will ask children, young people, and parents to try it out. In these interviews, investigators will ask if the questions make sense, are easy to understand, and feel relevant. This helps us refine and improve the questionnaire.
Recruitment and Interview Participants will be recruited from existing bronchiectasis database at the Birmingham Children's Hospital. Clinicians involved in routine care will screen eligible patients using pre-defined criteria.
Ideally new participants will be recruited for the second phase of the development of PQOL-B's where possible. But due to the rarity of the disease this may not always be possible to achieve. So, there may be some participants that will participate in both interview stages.
Consenting for interviews Potential participants will be provided with an age-appropriate participant information sheet and given adequate time to consider participation. Informed consent will be obtained from parents/guardians, and assent from children where appropriate - those 15years and younger.
Stage 1: Semi structured Interviews A schedule of open-ended questions has been developed to support data collection, with reference to existing literature and shaped by the research objectives.
Discussions will centre on participants' life experiences living with bronchiectasis or having a child diagnosed with the disease, the impact it has on daily living activities.
Individual, semi-structured open-ended interviews will be conducted where possible in person, or by a virtual online meeting (via Microsoft teams' platform) in accordance with participant preference, by the research team who have extensive training and experience in conducting qualitative interviews as well as extensive experience of working with children and their families living with bronchiectasis.
Interviews will be conducted by the research team and last approximately 45- 60 minutes, depending on how much the participant has to say.
Whether the interview is conducted in person or via video-call using Microsoft Teams, in accordance with participant preference, both ways will be recorded using the Microsoft Team's platform.
The recordings will be transcribed verbatim by the research team. The data will be accessible to the research team only, and investigators will only be sharing the anonymized transcripts for content analysis which includes an external collaborator as apart of the multi-disciplinary team, and this is for their expert academic input. Content analysis will be facilitated using NVivo software and will identify key themes, symptoms and impacts.
Ensuring no new information is emerging, and therefore saturation has been achieved.
Agreement on question selection and wording will be agreed during multi-disciplinary team discussions; these discussions will also include the results from a previously completed e-Delphi study, creating prototype of questionnaires ready for cognitive testing.
Stage 2: Cognitive testing Interview It is necessary to pre-test the prototype on the target population. Data will be collected using cognitive testing via an interview process. These Interviews will last approximately 45 minutes, depending on how much the participant has to say.
The method of the cognitive testing interview is as follows; Participants should complete the prototype PQOL-B using the instructions provided. Children must have the prototypes read to them.
After they have completed each section, they must complete a cognitive debriefing interview. The questions will be asked after each section and will seek to examine what the participants thought of the questions and why they choose their rating of each item.
Participants will be asked whether there were any words they did not understand or if any important content or impacts of bronchiectasis were missed.
The interviewer will record the interview via Microsoft Team's platform. The interview can be virtual or face to face interview, as per the patients/care givers preference. Any suggestion for change will be discussed with the research team. The recordings will be transcribed verbatim by the research team. The data will be further anonymised and will be accessible to the research team only, and an external collaborator for their expert academic input.
The results of the interviews will be used to form a translated final version of PQOL-B, ready for formal validation.
- Conditions
- Paediatric Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life questionnaires for paediatric Bronchiectasis
Scale: Quality of Life questionnaires for paediatric Bronchiectasis -Across 4 age and respondent questionnaires will be developed and testing on the population it is designed for.
Minimum: Not reported Maximum: Not reported Higher score: Not reported/not applicable Time frame: 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start30 Jul 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paediatric BronchiectasisStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728006
- Sponsor's protocol ID
- 367491
- Acronym
- CASTLE
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sex Participant age Ethnicity Age at diagnosis Years Time since diagnosis Years(SD) CT Scan - for confirmation of disease
Publications
Smith H, Yates D, Nagakumar P, Kenia P. Pediatric Bronchiectasis Quality-of-Life Questionnaire-What Does the Literature Say? Pediatr Pulmonol. 2026 Feb;61(2):e71490. doi: 10.1002/ppul.71490.
PubMed 41689271
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Paediatric Bronchiectasis Quality of Life Questionnaires
- ClinicalTrials.gov ID
- NCT07728006
- Acronym / sponsor ID
- CASTLE / 367491
- Conditions
- Paediatric Bronchiectasis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Jul 2026 (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 refine a disease-specific quality of life (QoL) questionnaire for children with bronchiectasis, informed by qualitative interviews with affected children, young people, and their parents.
The paediatric bronchiectasis- specific quality of life (PQOL-B) questionnaire will be developed across four demographics:
Children aged 8-12 years
Young people aged 13 -17 years
Parent-proxy for 2-5years
Parent-proxy for 6-12years
Detailed description
To develop and refine a disease-specific quality of life (QoL) questionnaire for children with bronchiectasis, informed by qualitative interviews with affected children, young people, and their parents.
The paediatric bronchiectasis- specific quality of life (PQOL-B) questionnaire will be developed across four demographics:
- Children aged 8-12 years
- Young people aged 13 -17 years
- Parent-proxy for 2-5years
- Parent-proxy for 6-12years
The development of the questionnaires will be carried out by conducting two different stages of interviews over a 12- month time period:
- Concept Elicitation - Semi structured interviews - will be to talk about what life is like living with bronchiectasis or living with a child who has bronchiectasis.
- Cognitive testing interviews - Once investigators create a first draft of the PQOL-B questionnaire, investigators will ask children, young people, and parents to try it out. In these interviews, investigators will ask if the questions make sense, are easy to understand, and feel relevant. This helps us refine and improve the questionnaire.
Recruitment and Interview Participants will be recruited from existing bronchiectasis database at the Birmingham Children's Hospital. Clinicians involved in routine care will screen eligible patients using pre-defined criteria.
Ideally new participants will be recruited for the second phase of the development of PQOL-B's where possible. But due to the rarity of the disease this may not always be possible to achieve. So, there may be some participants that will participate in both interview stages.
Consenting for interviews Potential participants will be provided with an age-appropriate participant information sheet and given adequate time to consider participation. Informed consent will be obtained from parents/guardians, and assent from children where appropriate - those 15years and younger.
Stage 1: Semi structured Interviews A schedule of open-ended questions has been developed to support data collection, with reference to existing literature and shaped by the research objectives.
Discussions will centre on participants' life experiences living with bronchiectasis or having a child diagnosed with the disease, the impact it has on daily living activities.
Individual, semi-structured open-ended interviews will be conducted where possible in person, or by a virtual online meeting (via Microsoft teams' platform) in accordance with participant preference, by the research team who have extensive training and experience in conducting qualitative interviews as well as extensive experience of working with children and their families living with bronchiectasis.
Interviews will be conducted by the research team and last approximately 45- 60 minutes, depending on how much the participant has to say.
Whether the interview is conducted in person or via video-call using Microsoft Teams, in accordance with participant preference, both ways will be recorded using the Microsoft Team's platform.
The recordings will be transcribed verbatim by the research team. The data will be accessible to the research team only, and investigators will only be sharing the anonymized transcripts for content analysis which includes an external collaborator as apart of the multi-disciplinary team, and this is for their expert academic input. Content analysis will be facilitated using NVivo software and will identify key themes, symptoms and impacts.
Ensuring no new information is emerging, and therefore saturation has been achieved.
Agreement on question selection and wording will be agreed during multi-disciplinary team discussions; these discussions will also include the results from a previously completed e-Delphi study, creating prototype of questionnaires ready for cognitive testing.
Stage 2: Cognitive testing Interview It is necessary to pre-test the prototype on the target population. Data will be collected using cognitive testing via an interview process. These Interviews will last approximately 45 minutes, depending on how much the participant has to say.
The method of the cognitive testing interview is as follows; Participants should complete the prototype PQOL-B using the instructions provided. Children must have the prototypes read to them.
After they have completed each section, they must complete a cognitive debriefing interview. The questions will be asked after each section and will seek to examine what the participants thought of the questions and why they choose their rating of each item.
Participants will be asked whether there were any words they did not understand or if any important content or impacts of bronchiectasis were missed.
The interviewer will record the interview via Microsoft Team's platform. The interview can be virtual or face to face interview, as per the patients/care givers preference. Any suggestion for change will be discussed with the research team. The recordings will be transcribed verbatim by the research team. The data will be further anonymised and will be accessible to the research team only, and an external collaborator for their expert academic input.
The results of the interviews will be used to form a translated final version of PQOL-B, ready for formal validation.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 2years to 17 years with a CT diagnosis of Paediatric Bronchiectasis -unrelated to CF or PCD. Also parents of children and young people aged 2years-12years with a CT diagnosis of Paediatric Bronchiectasis -unrelated to CF or PCD.
Key inclusion criteria (3 listed)
- Patient, child and young persons, aged 8 -17 years with bronchiectasis diagnosed on CT scan
Key exclusion criteria (3 listed)
- Child under 8 years with bronchiectasis for patient direct participation
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
Quality of Life questionnaires for paediatric Bronchiectasis
Time frame: 1 year
Scale: Quality of Life questionnaires for paediatric Bronchiectasis -Across 4 age and respondent questionnaires will be developed and testing on the population it is designed for. Minimum: Not reported Maximum: Not reported Higher score: Not reported/not applicable Time frame: 1 year
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 6 Oct 2026.
- Background: PubMed 41689271Smith H, Yates D, Nagakumar P, Kenia P. Pediatric Bronchiectasis Quality-of-Life Questionnaire-What Does the Literature Say? Pediatr Pulmonol. 2026 Feb;61(2):e71490. doi: 10.1002/ppul.71490.
- Individual participant dataSharing planned: Yes. Sex Participant age Ethnicity Age at diagnosis Years Time since diagnosis Years(SD) CT Scan - for confirmation of disease
Related trials for Paediatric Bronchiectasis
Recruiting
Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Paediatric Bronchiectasis, run by Birmingham Women's and Children's NHS Foundation Trust 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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 6 Oct 2026. 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?
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?
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?
Quality of Life questionnaires for paediatric Bronchiectasis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07728006, which also lists 1 linked publication.
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 6 Oct 2026.