Clinical trial · Observational
Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases
Development of a New Tool for Dyspnea Measurement (DYSLIM for Dyspnea Limitation) in Chronic Respiratory Diseases
NCT02229994CI-TRIAL-00097579DYSLIMcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COPD (With - Without Rehabilitation) | — | UNRESOLVED | — |
| Cystic Fibrosis of the Adult | — | UNRESOLVED | — |
| Diffuse Interstitial Lung Diseases | — | UNRESOLVED | — |
| Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults patients with chronic respiratory diseases
- description
- \- 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
- interventionNames
- Other: Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.
Primary outcomes (1)
- measure
- Psychometric validity of the questionnaire
- timeFrame
- Until end of treatment (making a total of 6 months)
- description
- Cross-sectional and longitudinal psychometric validation of a self-administered dyspnea questionnaire
Secondary outcomes (10)
- measure
- Analysis of responses distribution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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) * 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
References
Publications (0)
Data not yet available
No reference posted for this study.