Non Cystic Fibrosis BronchiectasisNCT06877091
Nutritional Status and Intake in Patients With Non-cystic Fibrosis Bronchiectasis (NCFB)
An observational study of Non Cystic Fibrosis Bronchiectasis, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The aim of this study was to characterise nutritional status and dietary intake in a population of individuals living with bronchiectasis from a regional clinic. Participants underwent usual assessment as per their standard pathway of care and in addition, body composition through skinfold measures, Handgrip strength… Read more about this study
- Who is it for?
- Ages 17 to 99 years
- Conditions the study is for
- Non Cystic Fibrosis Bronchiectasis
- How many people
- 129 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2017to 31 Jul 2018
- 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 17 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Those who attend the Leeds Regional Bronchiectasis Clinic
Who may be able to join
- People who have a confirmed diagnosis of NCFB
- people with NCFB who are clinically stable (not requiring acute admission to hospital)
- people who attend the regional clinic
Who cannot join
- People who are pregnant
- people with existing comorbidities such as malignancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals Trust
Leeds, West Yorkshire, LS9 &TF
About this study
Official title: Nutritional Status and Intake in Patients With Non-cystic Fibrosis Bronchiectasis (NCFB) - a Cross Sectional Study
The aim of this study was to characterise nutritional status and dietary intake in a population of individuals living with bronchiectasis from a regional clinic. Participants underwent usual assessment as per their standard pathway of care and in addition, body composition through skinfold measures, Handgrip strength and information on dietary intake over 3 days via 24 hour multiple pass recalls was also collected. This was to establish baseline measures and knowledge in support of understanding the impact of nutritional status within this group.
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Keywords
- Nutritional status, Dietary Intake, NCFB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Regional cohort of individuals living with Non-Cystic Fibrosis Bronchiectasis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Function (FEV1 )
Collect spirometry data that is measured as part of clinical care
Measured: At point of recruitment
Lung Function ( FVC)
Collect spirometry data that is measured as part of clinical care
Measured: At point of recruitment
Height (m)
Height will be taken to enable measurement of BMI
Measured: At point of recruitment
Weight (kg)
Weight will be taken to provide unit to calculate BMI (kg/m2)
Measured: At point of recruitment
BMI (kg/m2)
Collection of standard data (weight and height) from usual care pathway
Measured: At point of recruitment
Secondary outcomes (3)
Handgrip Dynamometry (kg/f)
Collection of hand grip strength to establish a mean value
Measured: At point of recruitment
Tricep Skinfold measurement (mm)
To measure triceps skinfold to determine estimated fat mass
Measured: At point of recruitment
Dietary intake checklist
To collect 3 separate 24 hour recalls over multiple days to establish mean reported intakes.
Measured: At point of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Jul 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Cystic Fibrosis 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Professor Daniel G Peckham, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877091
- Sponsor's protocol ID
- Version 1
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study was undertaken in 2017
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Intake in Patients With Non-cystic Fibrosis Bronchiectasis (NCFB) - a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06877091
- Acronym / sponsor ID
- Version 1
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Keywords
- Nutritional status, Dietary Intake, NCFB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 14 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.
The aim of this study was to characterise nutritional status and dietary intake in a population of individuals living with bronchiectasis from a regional clinic. Participants underwent usual assessment as per their standard pathway of care and in addition, body composition through skinfold measures, Handgrip strength and information on dietary intake over 3 days via 24 hour multiple pass recalls was also collected. This was to establish baseline measures and knowledge in support of understanding the impact of nutritional status within this group.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regional cohort of individuals living with Non-Cystic Fibrosis Bronchiectasis | – | – |
Who may qualify
- Ages
- 17 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those who attend the Leeds Regional Bronchiectasis Clinic
Key inclusion criteria (3 listed)
- People who have a confirmed diagnosis of NCFB
- people with NCFB who are clinically stable (not requiring acute admission to hospital)
- people who attend the regional clinic
Key exclusion criteria (2 listed)
- People who are pregnant
- people with existing comorbidities such as malignancy
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
Lung Function (FEV1 )
Time frame: At point of recruitment
Collect spirometry data that is measured as part of clinical care
Lung Function ( FVC)
Time frame: At point of recruitment
Collect spirometry data that is measured as part of clinical care
Height (m)
Time frame: At point of recruitment
Height will be taken to enable measurement of BMI
Weight (kg)
Time frame: At point of recruitment
Weight will be taken to provide unit to calculate BMI (kg/m2)
BMI (kg/m2)
Time frame: At point of recruitment
Collection of standard data (weight and height) from usual care pathway
3 secondary outcomes
Handgrip Dynamometry (kg/f)
Time frame: At point of recruitment
Tricep Skinfold measurement (mm)
Time frame: At point of recruitment
Dietary intake checklist
Time frame: At point of recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided. This study was undertaken in 2017
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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.
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 Non Cystic Fibrosis Bronchiectasis, run by University of Leeds 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 2 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: finished, as of the sponsor's last update on 14 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lung Function (FEV1 ) (time frame: At point of recruitment). The study lists 5 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 14 Mar 2025.