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Completed

NCT Number: NCT03898284

Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Respiratory Functional Explorations, University Hospital, Lille, Lille, France

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

impulse oscillometry

Diagnostic Test

Impulse Oscillometry will be performed in addition to usual care

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Receiver operating characteristics curves will be used to determine diagnostic performance.

  2. Performance of baseline impulse oscillometry parameters 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.

  3. Assess correlations between impulse oscillometry parameters and forced vital capacity

    Time frame: Baseline, 3 months, 6 months

    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)

  4. Assess correlations between impulse oscillometry parameters and exertional dyspnea

    Time frame: Baseline, 3 months, 6 months

    Dyspnea is assessed by the baseline dyspnea questionnaire and the transitional dyspnea questionnaire

  5. Assess correlations between impulse oscillometry parameters and the extent of either fibrosis or emphysema lesions on CT scans

    Time frame: Baseline

    Lesions are scored by trained observers.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: OSCILLO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2019
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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