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Reliability and Validity of iOS in IPF

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ClinicalTrials.gov Identifier: NCT04572971
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Study Description
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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
Idiopathic Pulmonary Fibrosis

Study Design
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Study Type : Observational
Estimated Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability and Validity of iOS in IPF
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. iOS measurements of reactance [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with IPF
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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)
  2. Unable to create seal on mouthpiece
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572971


Contacts
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Contact: Suhani Patel, MSc +4402073528121 ext 84972 s.patel1@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton and Harefield hospitals Recruiting
London, Gb-lnd, United Kingdom, SW36NP
Contact: Suhani Patel    +4402073528121 ext 84972    s.patel1@rbht.nhs.uk   
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04572971    
Other Study ID Numbers: 20/LO/0970
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases