COPD (With - Without Rehabilitation)DYSLIMNCT02229994
Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases
An observational study of COPD (With - Without Rehabilitation) and Diffuse Interstitial Lung Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is the psychometric validation of a self-administered dyspnea questionnaire, usable in clinical practice in order to assess dyspnea and its impact on patients with chronic respiratory diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (With - Without Rehabilitation), Diffuse Interstitial Lung Diseases, Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....)
- What is being tested?
- Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.
- How many people
- 199 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2010to 30 Dec 2015
- 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: Study Population are adults patients with chronic respiratory diseases (Sample1: COPD; Sample 2: Diffuse interstitial lung diseases; Sample 3: Pulmonary Arterial Hypertension primary or secondary (post embolic .....); Sample 4: Adult with Cystic fibrosis)
Who may be able to join
- 1) Sample1: COPD GOLD / ATS > 2 without major co-morbidity
- Sample 1A: n = 50: group of patients with no change in usual care and no acute event (evaluation of reproducibility)
- Sample1B: n = 60: patients assessed before and after a qualifying period of pulmonary rehabilitation
- 2) Sample 2 (n = 30): diffuse interstitial lung diseases Criteria: Pulmonary Fibrosis: Idiopathic or nonspecific interstitial lung diseases (NILD) according to international criteria (ATS), sarcoidosis with parenchymal lesions (old classification stage II and III), and exceptionally alveolar proteinosis.
- 3) Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post embolic .....).
- 4) Sample4 (n = 30): Adult with Cystic fibrosis.
- 5) patient with stable Status (no exacerbation for at least one month)
Who cannot join
- 1) Patient under 18 years
- 2) Inability to fill in questionnaires
- 3) Other respiratory disease
- 4) left symptomatic heart failure
- 5) Obesity with a BMI> 35 kg/m2
- 6) Inability to perform PFT (Pulmonary Function Testing)
Show all 10Show fewer
- 7) Pregnant or breastfeeding woman
- 8) Patient unable to consent
- 9) Lack of social insurance coverage
- 10) Patient in exclusion period because of another protocol
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre
Paris, 75006
About this study
Official title: Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases
The purpose of this study is the psychometric validation of a self-administered dyspnea questionnaire, usable in clinical practice in order to assess dyspnea and its impact on patients with chronic respiratory diseases.
Read the detailed description
Dyspnea is a cardinal Respiratory symptom.
According to the ATS dyspnea is the term used to characterize a subjective experience of breathing discomfort, covering qualitatively distinct sensations of varying intensity.
The subjective nature of dyspnea and the high complexity of its determinants explain the often moderate correlations obtained with physiological data. Dyspnea must therefore be measured specifically.
The aim of this study is the cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire (assessing the impact of dyspnea on activities restriction), usable in clinical practice in order to assess dyspnea and its alterations in adult patients with chronic respiratory diseases.
(COPD, diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis)
Like any psychometric instrument, an efficient evaluation of dyspnea scale should ideally satisfy all the following required features: evaluative, discriminant, good reproducibility, and high sensitivity to change.
The desired features apart from content validity are reproducibility and especially a high sensitivity to change, particularly following pulmonary rehabilitation.
Thus, this questionnaire should precisely enable to assess the benefit of rehabilitation and it's sustainment in maintenance phase.
- Conditions
- COPD (With - Without Rehabilitation), Diffuse Interstitial Lung Diseases, Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....), Cystic Fibrosis of the Adult
- Being tested
- Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.
- Keywords
- Dyspnea, Self-administered questionnaire, Chronic respiratory disease, COPD, Diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neoplasm Metastasis, Dyspnea, Pulmonary Arterial Hypertension, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.Other
Also called Self-administered dyspnea questionnaire
Evaluation will be performed on a group of 200 patients deriving from 4 samples.
- From these 200 patients, a sub-sample will be evaluated at 7 days (DYSLIM questionnaire only) for reproducibility (n = 50 patients: 10 patients with diffuse interstitial lung disease, 10 patients with cystic fibrosis, 10 patients with arterial pulmonary hypertension, 20 patients with COPD).
- From these 200 patients, a sub-sample (COPD, n = 60) will be recruited among patients undergoing pulmonary rehabilitation at the beginning of the 6 months separating follow up visit and the initial assessment.
| Study group | Role | What they receive |
|---|---|---|
| Adults patients with chronic respiratory diseases | - 200 adult patients with chronic respiratory diseases will be studied longitudinally and transversely (follow-up: 6 months) in 12 centres.
1. Sample 1 (n=110 patients) with COPD
2. Sample 2 (n=30 patients) with Diffuse interstitial lung diseases
3. Sample 3 (n=30 patients) with Pulmonary Arterial Hypertension primary or secondary (post embolic .....).
4. Sample 4 (n=30 patients) Adult with Cystic fibrosis Receives: Other: Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric validity of the questionnaire
Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
Secondary outcomes (10)
Analysis of responses distribution
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
Structural analysis (in principal components)
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
External and convergent validity
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
Internal coherence
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
Reproducibility
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
Reproducibility
for a sub sample of 50 patients, Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: 7 days
Discriminating properties
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
Derivation of a scoring algorithm
Cross-sectional and longitudinal data to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
Sensitivity to change
Sensitivity to change will be analyzed in relation to:
The TDI score, at the Likert scale on changes in dyspnea The scores of quality of life with their respective significant thresholds A the overall medical evaluation A changing EFR parameters with their respective significant thresholds (FEV, DLCO, walk test .....).
All this are the transversal data necessaries to assess the validation of a psychometric self-administered dyspnea questionnaire.
Measured: Until end of treatment (making a total of 6 months)
Minimal difference clinically relevant
Cross-sectional data necessary to assess the psychometric validity of a self-administered dyspnea questionnaire
Measured: Until end of treatment (making a total of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start16 Mar 2010
- Primary completion27 Mar 2014
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (With - Without Rehabilitation)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Thierry Perez, MD, Study chair, CHRU de Lille / Hôpital Calmette - FranceNicolas ROCHE, MD, PhD, Principal investigator, APHP- Hopital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229994
- Sponsor's protocol ID
- 2009-A00181-56
- Acronym
- DYSLIM
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2014
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases
- ClinicalTrials.gov ID
- NCT02229994
- Acronym / sponsor ID
- DYSLIM / 2009-A00181-56
- Conditions
- COPD (With - Without Rehabilitation), Diffuse Interstitial Lung Diseases, Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....), Cystic Fibrosis of the Adult
- Keywords
- Dyspnea, Self-administered questionnaire, Chronic respiratory disease, COPD, Diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris, URC-CIC Paris Descartes Necker Cochin
- Study start
- 16 Mar 2010 (actual)
- Primary completion
- 27 Mar 2014 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- 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.
The purpose of this study is the psychometric validation of a self-administered dyspnea questionnaire, usable in clinical practice in order to assess dyspnea and its impact on patients with chronic respiratory diseases.
Detailed description
Dyspnea is a cardinal Respiratory symptom.
According to the ATS dyspnea is the term used to characterize a subjective experience of breathing discomfort, covering qualitatively distinct sensations of varying intensity.
The subjective nature of dyspnea and the high complexity of its determinants explain the often moderate correlations obtained with physiological data. Dyspnea must therefore be measured specifically.
The aim of this study is the cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire (assessing the impact of dyspnea on activities restriction), usable in clinical practice in order to assess dyspnea and its alterations in adult patients with chronic respiratory diseases.
(COPD, diffuse interstitial lung diseases, Pulmonary arterial hypertension, Cystic fibrosis)
Like any psychometric instrument, an efficient evaluation of dyspnea scale should ideally satisfy all the following required features: evaluative, discriminant, good reproducibility, and high sensitivity to change.
The desired features apart from content validity are reproducibility and especially a high sensitivity to change, particularly following pulmonary rehabilitation.
Thus, this questionnaire should precisely enable to assess the benefit of rehabilitation and it's sustainment in maintenance phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults patients with chronic respiratory diseases | – | Other: Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.- 200 adult patients with chronic respiratory diseases will be studied longitudinally and transversely (follow-up: 6 months) in 12 centres. 1. Sample 1 (n=110 patients) with COPD 2. Sample 2 (n=30 patients) with Diffuse interstitial lung diseases 3. Sample 3 (n=30 patients) with Pulmonary Arterial Hypertension primary or secondary (post embolic .....). 4. Sample 4 (n=30 patients) Adult with Cystic fibrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population are adults patients with chronic respiratory diseases (Sample1: COPD; Sample 2: Diffuse interstitial lung diseases; Sample 3: Pulmonary Arterial Hypertension primary or secondary (post embolic .....); Sample 4: Adult with Cystic fibrosis)
Key inclusion criteria (7 listed)
- 1) Sample1: COPD GOLD / ATS > 2 without major co-morbidity
- 2) Sample 2 (n = 30): diffuse interstitial lung diseases Criteria: Pulmonary Fibrosis: Idiopathic or nonspecific interstitial lung diseases (NILD) according to international criteria (ATS), sarcoidosis with parenchymal lesions (old classification stage II and III), and exceptionally alveolar proteinosis.
- 3) Sample 3 (n = 30) primary or secondary arterial pulmonary hypertension (post embolic .....).
- 4) Sample4 (n = 30): Adult with Cystic fibrosis.
- 5) patient with stable Status (no exacerbation for at least one month)
Key exclusion criteria (10 listed)
- 1) Patient under 18 years
- 2) Inability to fill in questionnaires
- 3) Other respiratory disease
- 4) left symptomatic heart failure
- 5) Obesity with a BMI> 35 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.Also: Self-administered dyspnea questionnaireEvaluation will be performed on a group of 200 patients deriving from 4 samples. * From these 200 patients, a sub-sample will be evaluated at 7 days (DYSLIM questionnaire only) for reproducibility (n = 50 patients: 10 patients with diffuse interstitial lung disease, 10 patients with cystic fibrosis, 10 patients with arterial pulmonary hypertension, 20 patients with COPD). * From these 200 patients, a sub-sample (COPD, n = 60) will be recruited among patients undergoing pulmonary rehabilitation at the beginning of the 6 months separating follow up visit and the initial assessment. | Other | Adults patients with chronic respiratory diseases |
Primary outcome
Psychometric validity of the questionnaire
Time frame: Until end of treatment (making a total of 6 months)
Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire
10 secondary outcomes
Analysis of responses distribution
Time frame: Until end of treatment (making a total of 6 months)
Structural analysis (in principal components)
Time frame: Until end of treatment (making a total of 6 months)
External and convergent validity
Time frame: Until end of treatment (making a total of 6 months)
Internal coherence
Time frame: Until end of treatment (making a total of 6 months)
Reproducibility
Time frame: Until end of treatment (making a total of 6 months)
Reproducibility
Time frame: 7 days
Discriminating properties
Time frame: Until end of treatment (making a total of 6 months)
Derivation of a scoring algorithm
Time frame: Until end of treatment (making a total of 6 months)
Sensitivity to change
Time frame: Until end of treatment (making a total of 6 months)
Minimal difference clinically relevant
Time frame: Until end of treatment (making a total of 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 20 Nov 2025.
Related trials for COPD (With - Without Rehabilitation)
Active, not recruiting
Effects of Structural Integration on Chest Wall Expansion Among COPD Patients
COPD (With - Without Rehabilitation)
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.
Thierry Perez, MD study chair
CHRU de Lille / Hôpital Calmette - France
Nicolas ROCHE, MD, PhD principal investigator
APHP- Hopital Cochin
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 COPD (With - Without Rehabilitation) and Diffuse Interstitial Lung Diseases, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 10 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 20 Nov 2025. 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?
Psychometric validity of the questionnaire (time frame: Until end of treatment (making a total of 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 20 Nov 2025.