Dyspnea and Idiopathic Pulmonary Fibrosis

Pulmonary Fibrosis Clinical Trial

— DYS-PID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864990
• Other study ID #: 2019_62
• Secondary ID: 2020-A00803-36
• Status: Recruiting
• Start date: October 22, 2021
• Est. completion date: October 2025

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Cécile Chenivesse, MD,PhD
• Phone: 0320445962
• Email: cecile.chenivesse[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
France	Hop Calmette Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Santelys Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the sensory and affective components of dyspnea	Description and changes in sensory (SQ) and affective (A2) scores of the Multidimensional Dyspnea Profile (MDP) questionnaire	baseline, 6 months
Secondary	Evolution of dyspnea during activities of daily living	Description and changes in San Diego Shortness of Breath Questionnaire (SOBQ) score	baseline, 6 months
Secondary	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	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	baseline, 6 months
Secondary	Assess the prevalence of refractory dyspnea	Description of the prevalence of patients with visual anolog scale at rest > 3 or mMRC scale > 2	baseline, 6 months