Idiopathic Pulmonary FibrosisOSCILLONCT03898284
Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis, run by University Hospital, Tours at 4 sites in France.
Trial summary
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Impulse Oscillometry
- How many people
- 54 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Apr 2019to 27 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Idiopathic Pulmonary Fibrosis
Who may be able to join
- Age ≥ 45 years.
- Idiopathic Pulmonary Fibrosis defined Interstitial Lung Diseases with 1) lack of any known cause for Interstitial Lung Diseases and 2) either the "definite usual interstitial pneumonia" pattern at CT scan, or the usual interstitial pneumonia (definite, probable or possible) pattern at lung biopsy, according to the Lung Function Group of the French Pulmonology Society criteria.
Who cannot join
- History of chronic obstructive airway disease.
- History of congestive heart failure.
- Emphysema-fibrosis syndrome, defined as emphysematous lesions involving >15% of the lung area at the level of the aortic arch (upper lobes).
- History of lower respiratory infection or acute respiratory failure of any cause less than 90 days before inclusion.
- Opposition to data processing.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Respiratory Functional Explorations, University Hospital, Lille
Lille, 59037
Respiratory Functional Explorations, University Hospital, Nantes
Nantes, 44093
Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen
Rouen
Pulmonology Department, University Hospital, Tours
Tours, 37044
About this study
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response.
Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.
Read the detailed description
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response.
Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Impulse Oscillometry
- Keywords
- Idiopathic Pulmonary Fibrosis, Impulse Oscillometry, Forced Vital Capacity
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impulse OscillometryDiagnostic test
Impulse Oscillometry will be performed in addition to usual care
| Study group | Role | What they receive |
|---|---|---|
| Impulse Oscillometry | Patients with Idiopathic Pulmonary Fibrosis. The objective is to determine whether another lung function technique, impulse oscillometry, is of interest to identify disease progression before changes in forced vital capacity can be ascertained. Receives: Diagnostic Test: Impulse Oscillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the 5-Hz reactance of the respiratory system (Xsr5) variation at 3 months, for the diagnosis of rapid decline in lung function.
Receiver operating characteristics curves will be used to determine diagnostic performance.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (5)
Performance of the 3-month variation in additional impulse oscillometry parameters for the diagnosis of rapid decline in lung function
Receiver operating characteristics curves will be used to determine diagnostic performance.
Measured: Baseline, 3 months, 6 months
Performance of baseline impulse oscillometry parameters for the diagnosis of rapid decline in lung function
Receiver operating characteristics curves will be used to determine diagnostic performance.
Measured: Baseline, 3 months, 6 months
Assess correlations between impulse oscillometry parameters and forced vital capacity
Forced vital capacity is the total amount of air exhaled during the Forced expiratory volume test (how much air a person can exhale during a forced breath)
Measured: Baseline, 3 months, 6 months
Assess correlations between impulse oscillometry parameters and exertional dyspnea
Dyspnea is assessed by the baseline dyspnea questionnaire and the transitional dyspnea questionnaire
Measured: Baseline, 3 months, 6 months
Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans
Lesions are scored by trained observers.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start23 Apr 2019
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
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.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent PLANTIER, MD-PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898284
- Sponsor's protocol ID
- RIPH3-RNI18/OSCILLO
- Other IDs
- 2018-A02300-55
- Acronym
- OSCILLO
- Status last verified
- Nov 2021
- First submitted
- 26 Feb 2019
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03898284
- Acronym / sponsor ID
- OSCILLO / RIPH3-RNI18/OSCILLO
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Impulse Oscillometry, Forced Vital Capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 1 Apr 2019 (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.
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response.
Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.
Detailed description
A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response.
Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impulse Oscillometry | – | Diagnostic Test: Impulse OscillometryPatients with Idiopathic Pulmonary Fibrosis. The objective is to determine whether another lung function technique, impulse oscillometry, is of interest to identify disease progression before changes in forced vital capacity can be ascertained. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Idiopathic Pulmonary Fibrosis
Key inclusion criteria (2 listed)
- Age ≥ 45 years.
- Idiopathic Pulmonary Fibrosis defined Interstitial Lung Diseases with 1) lack of any known cause for Interstitial Lung Diseases and 2) either the "definite usual interstitial pneumonia" pattern at CT scan, or the usual interstitial pneumonia (definite, probable or possible) pattern at lung biopsy, according to the Lung Function Group of the French Pulmonology Society criteria.
Key exclusion criteria (5 listed)
- History of chronic obstructive airway disease.
- History of congestive heart failure.
- Emphysema-fibrosis syndrome, defined as emphysematous lesions involving >15% of the lung area at the level of the aortic arch (upper lobes).
- History of lower respiratory infection or acute respiratory failure of any cause less than 90 days before inclusion.
- Opposition to data processing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impulse OscillometryImpulse Oscillometry will be performed in addition to usual care | Diagnostic test | Impulse Oscillometry |
Primary outcome
Performance of the 5-Hz reactance of the respiratory system (Xsr5) variation at 3 months, for the diagnosis of rapid decline in lung function.
Time frame: Baseline, 3 months, 6 months
Receiver operating characteristics curves will be used to determine diagnostic performance.
5 secondary outcomes
Performance of the 3-month variation in additional impulse oscillometry parameters for the diagnosis of rapid decline in lung function
Time frame: Baseline, 3 months, 6 months
Performance of baseline impulse oscillometry parameters for the diagnosis of rapid decline in lung function
Time frame: Baseline, 3 months, 6 months
Assess correlations between impulse oscillometry parameters and forced vital capacity
Time frame: Baseline, 3 months, 6 months
Assess correlations between impulse oscillometry parameters and exertional dyspnea
Time frame: Baseline, 3 months, 6 months
Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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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.
Laurent PLANTIER, MD-PhD study director
University Hospital, Tours
4 sites 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 University Hospital, Tours at 4 sites in France.
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 5 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: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance of the 5-Hz reactance of the respiratory system (Xsr5) variation at 3 months, for the diagnosis of rapid decline in lung function. (time frame: Baseline, 3 months, 6 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 11 Nov 2021.