Pulmonary FibrosisDYS-PIDNCT04864990
Dyspnea and Idiopathic Pulmonary Fibrosis
An observational study of Pulmonary Fibrosis, run by University Hospital, Lille at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2021to 7 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients with a diagnosis of idiopathic pulmonary fibrosis (IPF) and reporting dyspnea
Who may be able to join
- diagnosis of IPF according to ATS/ERS guidelines
- dyspnea at rest (VAS ≥ 1) or on exertion (mMRC ≥ 1)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dyspnea in Idiopathic Pulmonary Fibrosis (IPF): Multidimensional Assessment and Correlations With Lung Function
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
Read the 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.
- Conditions
- Pulmonary Fibrosis
- Medical subject headings
- Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 months
Secondary outcomes (3)
Evolution of dyspnea during activities of daily living
Description and changes in San Diego Shortness of Breath Questionnaire (SOBQ) score
Measured: baseline, 6 months
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
Measured: baseline, 6 months
Assess the prevalence of refractory dyspnea
Description of the prevalence of patients with visual anolog scale at rest > 3 or mMRC scale > 2
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start22 Oct 2021
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Santelys Association
- Responsible party
- Sponsor
- Investigators
- Cécile Chenivesse, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864990
- Sponsor's protocol ID
- 2019_62
- Other IDs
- 2020-A00803-36
- Acronym
- DYS-PID
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2021
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyspnea in Idiopathic Pulmonary Fibrosis (IPF): Multidimensional Assessment and Correlations With Lung Function
- ClinicalTrials.gov ID
- NCT04864990
- Acronym / sponsor ID
- DYS-PID / 2019_62
- Conditions
- Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Santelys Association
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with a diagnosis of idiopathic pulmonary fibrosis (IPF) and reporting dyspnea
Key inclusion criteria (2 listed)
- diagnosis of IPF according to ATS/ERS guidelines
- dyspnea at rest (VAS ≥ 1) or on exertion (mMRC ≥ 1)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Evolution of dyspnea during activities of daily living
Time frame: baseline, 6 months
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
Assess the prevalence of refractory dyspnea
Time frame: baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Chenivesse, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the sensory and affective components of dyspnea (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.