DYS-PID: Dyspnea and Idiopathic Pulmonary Fibrosis

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04864990
Collaborator
Santelys Association (Other)
50
1
47.3
1.1

Study Details

Study Description

Brief Summary

Longitudinal prospective exploratory study on the evolution of dyspnea, in its sensory and affective dimensions, in patients followed for idiopathic pulmonary fibrosis (IPF), between inclusion and a 6-month evaluation

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Dyspnea is a multidimensional experience involving a sensory component and an affective component. To better understand this symptom in IPF, this study will describe the different component of dyspnea and their evolution between inclusion and a 6-month evaluation in IPF patients.

    There is no strong correlation between the intensity of dyspnea and respiratory function impairments. Innovative techniques demonstrated abnormalities in ventilation variability and pulmonary compliance in patients with interstitial lung disease. These abnormalities could be more relevant to explain dyspnea. The objective of this work is also to assess the link between the different dimensions of dyspnea and respiratory functional parameters, ventilation variability and ventilatory mechanics measured by impulse oscillometry technique.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dyspnea in Idiopathic Pulmonary Fibrosis (IPF): Multidimensional Assessment and Correlations With Lung Function
    Actual Study Start Date :
    Oct 22, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2025
    Anticipated Study Completion Date :
    Oct 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Evolution of the sensory and affective components of dyspnea [baseline, 6 months]

      Description and changes in sensory (SQ) and affective (A2) scores of the Multidimensional Dyspnea Profile (MDP) questionnaire

    Secondary Outcome Measures

    1. Evolution of dyspnea during activities of daily living [baseline, 6 months]

      Description and changes in San Diego Shortness of Breath Questionnaire (SOBQ) score

    2. Association between the sensory and affective components of dyspnea and quality of life, anxiety symptoms, lung volumes, gas exchanges, ventilation variability, pulmonary compliance, pulmonary hypertension [baseline, 6 months]

      Correlation between SQ and A2 scores of the MDP questionnaire and King's Brief Interstitial Lung Disease (K-BILD) questionnaire score, State Trait Anxiety Inventory (STAI-Y2) score, lung volumes measured by plethysmography, DLCO, PaO2, delta of desaturation during the 6-minute walk test, coefficient of variation of the tidal volume at rest, impulse oscillometry reactance, systolic pulmonary artery pressure assessed by cardiac ultrasound

    3. Assess the prevalence of refractory dyspnea [baseline, 6 months]

      Description of the prevalence of patients with visual anolog scale at rest > 3 or mMRC scale > 2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • diagnosis of IPF according to ATS/ERS guidelines

    • dyspnea at rest (VAS ≥ 1) or on exertion (mMRC ≥ 1)

    Exclusion Criteria:
    • diffuse interstitial lung disease other than IPF

    • other significant chronic pathology that may cause dyspnea: chronic obstructive pulmonary disease, asthma, heart failure, anemia, obesity (non-exhaustive list), except for pulmonary hypertension

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hop Calmette Chu Lille Lille France 59037

    Sponsors and Collaborators

    • University Hospital, Lille
    • Santelys Association

    Investigators

    • Principal Investigator: Cécile Chenivesse, MD,PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04864990
    Other Study ID Numbers:
    • 2019_62
    • 2020-A00803-36
    First Posted:
    Apr 29, 2021
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2022