ClinicalTrials.gg
RecruitingNCT06326957SELF-BREATHEUpdated Jun 13, 2025

Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE)

An interventional study of SELF-BREATHE in Chronic Obstructive Pulmonary Disease, Bronchiectasis and Interstitial Lung Disease, sponsored by King's College Hospital NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
246
Allocation
Randomized
Ages
18 Years to 110 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 620 studies in Pulmonary Disease, Chronic Obstructive with a site in United Kingdom — 60 open to participants now, 75 under way, 10 of them phase 3. Pulmonary Disease, Chronic Obstructive · United Kingdom.

Planned enrollment
131st of 465
246 · median 80
Started
2024
with 17 others
No phase
122 of 620
10 open now
Primary completion
2028-02
later than 60 of 74 live
Registered
573rd of 620
by date

Among the 620 studies in Pulmonary Disease, Chronic Obstructive with a site in United Kingdom, this one is the 131st largest by planned enrollment of the 465 interventional ones that give a count, is one of 18 that started in 2024, is one of 122 with no phase, reaches primary completion later than 60 of the 74 other live ones, and was the 573rd registered.

Pulmonary Disease, Chronic Obstructive

5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

60 of the 620 studies in Pulmonary Disease, Chronic Obstructive with a site in United Kingdom are open now. Recruiting first, the newest first:

55 more — sign in →

All 60 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.

This study: 18 Years to 110 Years · all sexes · no healthy volunteers.

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02

Study summary

Background:

Some health conditions make breathing difficult and uncomfortable. When this happens every day, it is called chronic breathlessness. Over 3 million people living with heart and lung disease have chronic breathlessness in the UK.

Breathlessness is very difficult for patients themselves and their families, resulting in disability and feelings of fear, distress, and isolation. Due a to lack of supportive breathlessness services many patients frequently attend hospital Accident and Emergency (A\&E) departments seeking help.

Given the on-going challenges faced by the National Health Service (NHS) in the United Kingdom, such as long waiting times, staff shortages, increased demand for services because of the COVID-19 pandemic, there is an urgent need to develop new ways to support those living with chronic breathlessness. One potential solution is to offer support online, as it is estimated that in the UK, 7 out of every 10 people with chronic breathlessness are internet users.

With the help of patients and NIHR funding the research team lead by Dr Charles Reilly, developed an online breathlessness supportive website called SELF-BREATHE. SELF-BREATHE provides information and self-management tools such as breathing exercises, that patients can do at home themselves.

SELF-BREATHE has been tested as part of its development. SELF-BREATHE is acceptable and valued by patients. But what is unknown is whether SELF-BREATHE improves patients' breathlessness and their life? This is the question this research seeks to answer.

Aims

  1. To test if using SELF-BREATHE for six-weeks improves patients' breathlessness, their quality of life and whether SELF-BREATHE should be offered within the NHS
  2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients.

Methods

The research team are undertaking a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited in to this study. Each person will be randomly chosen by a computer to continue with their usual care or their usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at seven and twelve weeks after randomisation.

These questionnaires will ask patients about 1) their breathlessness and its effect on their life and 2) planned and unplanned hospital visits. At the end of the study, we will compare answers to these questionnaires between the two groups at seven and 12 weeks.

This will tell if SELF-BREATHE improved patients' breathlessness and reduced their need for unplanned hospital visits e.g., A\&E attendances due to breathlessness.

03

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Bronchiectasis
  • Interstitial Lung Disease
  • Lung Cancer
  • Asthma
  • Dyspnea
  • Fibrotic Lung Disease
  • Chronic Lung Disease
04

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults ≥ 18 years of age
  • Chronic Breathlessness at rest and / or exertion
  • Chronic Breathlessness (CB) defined as breathlessness that persists (>3months) despite pharmacological treatment of the underlying disease including, but not limited to; cancer, (COPD), interstitial lung disease (ILD), bronchiectasis, chronic fibrotic lung disease following SARS-CoV2 infection
  • Medical Research Council (MRC) dyspnea score ≥ 2 (MRC 2= short of breath when hurrying on the level or walking up a slight hill
  • Availability to a computer, tablet, or smart phone with internet access
  • Able to provide .

Exclusion criteria

Exclusion Criteria:

  • Breathlessness of unknown cause
  • Primary diagnosis of chronic hyperventilation syndrome
  • Currently participating in a rehabilitation programme e.g.,pulmonary/cardiac rehabilitation (patients that have completed PR >4-weeks will be eligible).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
246 participants (estimated)

Study arms

  • Experimental
    SELF-BREATHE (Intervention)

    SELF-BREATHE + usual NHS care (Intervention)

    Other: SELF-BREATHE

  • No intervention
    Usual NHS care (Control)

    Participants randomised to the control group continue with usual NHS care, as was available to them prior to entry into the trial

Interventions

  • OtherSELF-BREATHE

    SELF-BREATHE is on online supportive self - management intervention for individuals living with chronic breathlessness due to respiratory disease. SELF-BREATHE provides user with educational resources about breathlessness and self - management techniques such as breathing exercises, goal setting which aims to help with their breathlessness.

06

What researchers measure

Primary outcomes

  1. Numerical Rating Scale (NRS) Worst Breathlessness

    The primary outcome is patient rated intensity of worst breathlessness over the previous 24 hours, using a validated 11-point (0-10) numerical rating scale (NRS), where 0 = no breathlessness, and 10 = worst imaginable breathlessness (Patient self-reported out-come measure)

    Time frame: previous 24 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Feb 2028, 43 months after the start.

Of 1,095 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 43 months is above that.

Counting every sponsor, half of 1,182 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2024
First posted
Mar 22, 2024
StartActual
Jul 4, 2024
Primary completionEst.
Feb 2028
CompletionEst.
Jul 2028
Last update
Jun 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06326957
Responsible party
Sponsor
First posted
Mar 22, 2024
Start date
Jul 4, 2024
Primary completion
Feb 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Jun 13, 2025

Study contacts

Charles C Reilly, PhD,MSc,BSc
Contact
charles.reilly@nhs.net
00442032998062
Charles C Reilly, PhD,MSc,BSc
principal investigator · King's College Hospital NHS Foundation Trust, King's College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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