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Changes in iOS in IPF

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ClinicalTrials.gov Identifier: NCT04572958
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : March 15, 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 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.


Condition or disease
Idiopathic Pulmonary Fibrosis

Study Design
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Study Type : Observational
Estimated Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Impulse Oscillometry Measurements and Outcomes in Idiopathic Pulmonary Fibrosis
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : January 2027

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. Oscillometry measurements of reactance [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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): NCT04572958


Contacts
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Contact: Suhani Patel +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: NCT04572958    
Other Study ID Numbers: LO/0969
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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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
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases