Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis (OSCILLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03898284
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief 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. 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.


Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Diagnostic Test: Impulse Oscillometry

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021


Group/Cohort Intervention/treatment
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.
Diagnostic Test: Impulse Oscillometry
Impulse Oscillometry will be performed in addition to usual care




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Idiopathic Pulmonary Fibrosis
Criteria

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.

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): NCT03898284


Contacts
Layout table for location contacts
Contact: Laurent PLANTIER, MD-PhD 02 47 47 98 44 ext +33 laurent.plantier@univ-tours.fr

Locations
Layout table for location information
France
Respiratory Functional Explorations, University Hospital, Lille Not yet recruiting
Lille, France, 59037
Contact: Thierry PEREZ, MD         
Principal Investigator: Thierry PEREZ, MD         
Respiratory Functional Explorations, University Hospital, Nantes Not yet recruiting
Nantes, France, 44093
Contact: Arnaud Arnaud, MD         
Principal Investigator: Arnaud Arnaud, MD         
Department of digestive physiology, urinary, respiratory and exercise, University Hospital, Rouen Not yet recruiting
Rouen, France
Contact: Marie NETCHITAILO, MD         
Principal Investigator: Marie NETCHITAILO, MD         
Pulmonology Department, University Hospital, Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Layout table for investigator information
Study Director: Laurent PLANTIER, MD-PhD University Hospital, Tours

Layout table for additonal information
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03898284     History of Changes
Other Study ID Numbers: RIPH3-RNI18/OSCILLO
2018-A02300-55 ( Other Identifier: IdRCB )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Tours:
Idiopathic Pulmonary Fibrosis
Impulse Oscillometry
Forced Vital Capacity

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial