Status:
COMPLETED
Development of a New Tool for Dyspnea Measurement in Chronic Respiratory Diseases
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Pr Joel COSTE, Hôpital Hôtel Dieu - Unité de Bio Statistiques et Epidémiologiques, Paris
URC-CIC Paris Descartes Necker Cochin
Conditions:
COPD (With - Without Rehabilitation)
Diffuse Interstitial Lung Diseases
Eligibility:
All Genders
18+ years
Brief 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 re...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2015
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT02229994
Start Date
March 16 2010
End Date
December 30 2015
Last Update
November 20 2025
Active Locations (1)
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1
Service de Pneumologie AP-HP, Hôpitaux Universitaires Paris Centre
Paris, France, 75006