Idiopathic Pulmonary FibrosisNCT04572958
Changes in iOS in IPF
An observational study of Idiopathic Pulmonary Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2020to May 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients with IPF
Who may be able to join
- Diagnosis of idiopathic pulmonary fibrosis made by specialist multidisciplinary team according to international standards
- Able to provide written informed consent
Who cannot join
- Contraindication to performing conventional lung function tests, e.g untreated TB, haemoptysis, pneumothorax, unstable cardiovascular status, recent eye, thoracic or abdominal surgery, thoracic, abdominal or cerebral aneurysm, acute illness (including diarrhoea and vomiting).
- Unable to create seal on mouthpiece
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield hospitals
London, Gb-lnd, SW36NP
About this study
Official title: Changes in Impulse Oscillometry Measurements and Outcomes in Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. People with IPF complain of worsening breathlessness, which limits their day to day activities.
Lung function tests are breathing tests that measure how well your lungs are working, and are used by doctors to decide whether to start or stop medicines in people with IPF. However, people with IPF tell us that lung function tests require a lot of effort, can make them cough and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung function results accurately. This might unfairly lead to some people with IPF not receiving the right medications or for their medications to be stopped too soon.
Read more
Impulse oscillometry (iOS) uses sound waves to measure the stiffness of the lung, and has been used successfully in children who are unable to perform normal lung function tests.
The overall aim of the research is to see whether changes in iOS measures can give useful information about the lungs in patients with IPF; for example, by judging the overall impact of the disease on the lungs, or predicting future deterioration.
We will look at how iOS changes over time in patients with IPF, and to see whether these measurements can tell us about whether IPF is getting worse or predict important health events, such as hospital admission. We will compare change in iOS with changes in other tests used to monitor IPF and with patient reported ratings of change in their condition. This will help decide the amount of iOS change that is noticed and considered meaningful by people with IPF.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Oscillometry measurements of reactance
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start6 Nov 2020
- Primary completion5 May 2022
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572958
- Sponsor's protocol ID
- LO/0969
- Status last verified
- May 2022
- First submitted
- 26 Sep 2020
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Impulse Oscillometry Measurements and Outcomes in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04572958
- Acronym / sponsor ID
- LO/0969
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Oct 2020 (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.
Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. People with IPF complain of worsening breathlessness, which limits their day to day activities.
Lung function tests are breathing tests that measure how well your lungs are working, and are used by doctors to decide whether to start or stop medicines in people with IPF. However, people with IPF tell us that lung function tests require a lot of effort, can make them cough and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung function results accurately. This might unfairly lead to some people with IPF not receiving the right medications or for their medications to be stopped too soon.
Impulse oscillometry (iOS) uses sound waves to measure the stiffness of the lung, and has been used successfully in children who are unable to perform normal lung function tests.
The overall aim of the research is to see whether changes in iOS measures can give useful information about the lungs in patients with IPF; for example, by judging the overall impact of the disease on the lungs, or predicting future deterioration.
We will look at how iOS changes over time in patients with IPF, and to see whether these measurements can tell us about whether IPF is getting worse or predict important health events, such as hospital admission. We will compare change in iOS with changes in other tests used to monitor IPF and with patient reported ratings of change in their condition. This will help decide the amount of iOS change that is noticed and considered meaningful by people with IPF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with IPF
Key inclusion criteria (2 listed)
- Diagnosis of idiopathic pulmonary fibrosis made by specialist multidisciplinary team according to international standards
- Able to provide written informed consent
Key exclusion criteria (2 listed)
- Contraindication to performing conventional lung function tests, e.g untreated TB, haemoptysis, pneumothorax, unstable cardiovascular status, recent eye, thoracic or abdominal surgery, thoracic, abdominal or cerebral aneurysm, acute illness (including diarrhoea and vomiting).
- Unable to create seal on mouthpiece
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
Oscillometry measurements of reactance
Time frame: 12 months
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 5 May 2022.
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary 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. 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 Idiopathic Pulmonary Fibrosis, run by Royal Brompton & Harefield 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 2 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2022. 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?
Oscillometry measurements of reactance (time frame: 12 months). 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 5 May 2022.