Early Detection of Pulmonary Exacerbations in Non-cystic Fibrosis Bronchiectasis

Non-cystic Fibrosis Bronchiectasis Clinical Trial

— Bronch-EX  

Official title:

Early Detection of Pulmonary Exacerbations in Non-cystic Fibrosis Bronchiectasis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06151366
• Other study ID #: P03012
• Secondary ID: 323297
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Papworth Hospital NHS Foundation Trust
• Contact: Lucy Gale
• Phone: 01223638480
• Email: lucy.gale1[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the use of equipment to monitor health at home in participants who have non-cystic fibrosis bronchiectasis. The main question[s] it aims to answer are:

• How acceptable participants find using home monitoring equipment.

• To find out if the data collected from home monitoring can help to detect chest infections (exacerbations) before participants get symptoms they are aware of.

Participants will be provided with -

• a handheld spirometer to record FEV1 (lung function)

• a Fitbit, or other compatible activity monitor, to record activity and heart rate

• a saturation monitor that fits painlessly on the end of the finger to record oxygen levels

• weighing scales to record weight

• a mini freezer and pre-labelled sample containers to store a daily sputum sample. There is enough room in the freezers for samples to be brought to routine clinic visits. We will provide a cool bag and freezer packs for this. A courier collection of the samples can be arranged if necessary.

Participants will be encouraged to perform lung function, activity and oxygen levels at least 4 x per week.

Participants will be guided through how to set up and use each piece of equipment by the research team. The devices all connect to a smartphone app called Breathe RM (Remote Monitor,) which is free to download, via Bluetooth. Once set up using the home monitoring devices and adding notes to the app should take no more than 15 minutes per day.

Participants will be asked to record in the app -

• episodes of pulmonary exacerbation that require antibiotic treatment

• their coughing and wellness scores daily

Description:

The aim of the study is to find out if data collected from home monitoring and artificial intelligence (AI) in patients with non-Cystic Fibrosis bronchiectasis can be used to detect pulmonary exacerbations (chest infections) before participants get symptoms of an infection. The infection can then be treated sooner and therefore potentially reduce long term lung damage. This study builds on previous work that has been done with patients who have a lung condition called cystic fibrosis and has shown favourable results. The AI technology relates to the predictive algorithm and not to any devices.

Potential participants will be approached during routine clinic visits (face to face or virtual) to offer more information regarding the study, provided with written and verbal information, given the opportunity to ask questions and given ample time to make a decision regarding whether or not they would like to take part.

Fifty patients from Royal Papworth Hospital who have a diagnosis of non-Cystic Fibrosis Bronchiectasis and who have a history of one or more pulmonary exacerbations in the previous year will be asked to perform home monitoring, record episodes of infection and provide a daily sputum sample for 6 months.

Participants will be provided with -

• a handheld spirometer to record Forced expiratory volume in 1 second (FEV1) (lung function)

• a Fitbit, or other compatible activity monitor, to record activity and heart rate

• a saturation monitor that fits painlessly on the end of the finger to record oxygen levels

• weighing scales to record weight

• a mini freezer and pre-labelled sample containers to store a daily sputum sample. There is enough room in the freezers for samples to be brought to routine clinic visits. We will provide a cool bag and freezer packs for this. A courier collection of the samples can be arranged if necessary.

Participants will be encouraged to perform lung function, activity and oxygen levels at least 4 x per week.

Participants will be guided through how to set up and use each piece of equipment by the research team. The devices all connect to a smartphone app called Breathe RM (Remote Monitor) (free to download) via Bluetooth. Once set up using the home monitoring devices and adding notes to the app should take no more than 15 minutes per day.

Participants will be asked to record in the app -

• episodes of pulmonary exacerbation that require antibiotic treatment

• coughing and wellness scores daily

We want to find out how participants find performing home monitoring and what impact it has on quality of life. To assess this we will ask participants to complete a questionnaire to find out how acceptable they find using the equipment and app at home and a questionnaire that gives information regarding quality of life. These questionnaires can be provided on paper or electronically depending on participant preference. They should take no more than 15 minutes each to complete. The acceptability questionnaire will be taken 3 months into the study and at the end of the study. The quality-of-life questionnaire will be taken at the start, middle and end of the study. If a participant withdraws they will be asked to perform the questionnaires at this time.

Participants who use a nebuliser will be given the option to change to a Pari eFlow rapid nebuliser with Pari Connect. The nebuliser connects to an app on their smartphone via Bluetooth and monitors how often the participant takes their inhaled medications. Participants will be guided through how to use this equipment.

A score of how breathless participants (MRC Dyspnoea Scale) are and how severe the bronchiectasis (Bronchiectasis Severity Index) is will be performed at the start and end of the study by the clinical or research team and takes a few minutes.

Participants will be invited to virtual groups or one to one discussions to give feedback to the research team regarding the experience of being on the study. This is voluntary and participants will not be identified when the study is written up for publication.

Participants will be provided with a phone number and email address to contact the research team during office hours with any study related issues. All clinical queries should be directed to the clinical team as usual. Participants can withdraw at any time and it will have no impact on their care.

Results of the study will be made available through email, text, newsletters, hospital social media and virtual group / individual discussions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Under the care of the Lung Defence Clinic at Royal Papworth Hospital

• CT confirmed diagnosis of bronchiectasis

• Age >/= 18 years

• Had two or more clinician defined APEs in the year prior to enrolment

• Typically expectorates sputum daily

• Considered suitable for home monitoring in the opinion of the investigator

• Able to provide written informed consent

Exclusion Criteria:

• Patients unable to provide written informed consent

• Known cystic fibrosis

• Lung transplant recipients or on lung transplant waiting list

• Use of long-term oxygen therapy (LTOT) or non-invasive ventilation to manage respiratory failure

• Patients unwilling to consent to their link anonymised data from home monitoring being used for research

• Patients unable to use a smartphone. Patients who would like to take part but do not have a smartphone can be provided with one.

• Patients who do not have reliable Wi-Fi at home or are unable to access public Wi-Fi at least twice per week.

• Considered unsuitable for home monitoring in the opinion of the investigator

Related Conditions & MeSH terms

• Bronchiectasis
• Fibrosis
• Non-cystic Fibrosis Bronchiectasis

Intervention

Other:
• non interventional
non interventional

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	LifeArc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in the bronchiectasis impact measure scores at 6 months compared to baseline	The Bronchiectasis Impact Measure is a validated, patient reported outcome measure across 8 domains (cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) and the impact they have on daily life. It is measured on a scale on 0 to 10 with 0 being no impact on daily life and 10 being greatly impacts daily life (lower score better). Minimum score 0 maximum score 10. Higher score mean worse outcome.	baseline and month 6
Secondary	The acceptability of home monitoring in participants with non-cystic fibrosis bronchiectasis	Comparison of user acceptance questionnaire scores at 3 and 6 months. This is on a 5 point Likert scale with 5 being least acceptable and 1 being most acceptable. Higher score means worse outcomes.	3 months and 6 months
Secondary	Impact of home monitoring on acute exacerbation frequency	Number of days requiring antibiotics for acute pulmonary exacerbation at baseline and 6 months. Minimum score 0. Maximum score 365. Higher score means worse outcomes.	In preceding 12 months and at 6 months