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NCT Number: NCT04864990

Dyspnea and Idiopathic Pulmonary Fibrosis

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

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Key information

Conditions

Pulmonary Fibrosis Fibrosis Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Calmette Chu Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Evolution of the sensory and affective components of dyspnea

    Time frame: baseline, 6 months

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

Secondary outcomes

  1. Evolution of dyspnea during activities of daily living

    Time frame: 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

    Time frame: 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

    Time frame: baseline, 6 months

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Santelys Association

Registry information

Official study title

Dyspnea in Idiopathic Pulmonary Fibrosis (IPF): Multidimensional Assessment and Correlations With Lung Function

Acronym: DYS-PID

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2021
Registry last updated
Apr 7, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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