Reliability and Validity of iOS in IPF

Sponsor

Royal Brompton & Harefield NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT04572971

Collaborator

(none)

Enrollment

Location

16.7

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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. People with IPF complain of worsening breathlessness, which limits their day to day activities.

Lung function tests are breathing tests that measure how well the 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.

Impulse oscillometry (iOS) is a new type of breathing test. It uses sound waves to measure the stiffness of the lung. The test is very quick (30 seconds), does not require any effort from the patient, and only requires a patient to breathe in their usual way. iOS has been used successfully in children who are unable to perform normal lung function tests.

The investigators will assess whether people with IPF can perform iOS tests accurately and to compare their experiences of having iOS tests with their experience of performing current lung function tests. The investigators will also compare whether there is a relationship between iOS tests and the information gathered from the tests currently used by doctors to measure the impact of IPF (lung function tests, exercise tests, lung scans and questionnaires that measure quality of life).

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis

Study Design

Study Type:

Observational

Actual Enrollment :

78 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Reliability and Validity of iOS in IPF

Actual Study Start Date :

Nov 6, 2020

Actual Primary Completion Date :

Mar 30, 2022

Actual Study Completion Date :

Mar 30, 2022

Outcome Measures

Primary Outcome Measures

iOS measurements of reactance [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of idiopathic pulmonary fibrosis made by specialist multidisciplinary team according to international standards
Able to provide written informed consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Brompton and Harefield hospitals	London	Gb-lnd	United Kingdom	SW36NP

Sponsors and Collaborators

Royal Brompton & Harefield NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Royal Brompton & Harefield NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04572971

Other Study ID Numbers:

20/LO/0970

First Posted:

Oct 5, 2020

Last Update Posted:

May 5, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Study Results

No Results Posted as of May 5, 2022