Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04864990
Other study ID # 2019_62
Secondary ID 2020-A00803-36
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04638517 - The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis Phase 2
Recruiting NCT05299333 - Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis N/A
Terminated NCT04119115 - Integrated Radiographic and Metabolomics Risk Assessment in Patients With Interstitial Lung Diseases
Not yet recruiting NCT05890573 - Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19 N/A
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT01417156 - Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174) Phase 2
Terminated NCT00981747 - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis Phase 2/Phase 3
Completed NCT00001596 - Oral Pirfenidone for the Pulmonary Fibrosis of Hermansky-Pudlak Syndrome Phase 2
Completed NCT00052052 - An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT01442779 - Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT00366509 - Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
Recruiting NCT00001532 - Role of Genetic Factors in the Development of Lung Disease
Recruiting NCT04767074 - A Non-pharmacological Cough Control Therapy N/A
Completed NCT01961362 - Supplemental Oxygen in Pulmonary Fibrosis
Completed NCT01271842 - Long-term Outcome and Lung Capacity in Survivors of ARDS Due to Influenza A (H1N1) v2009 The RESPIFLU Study N/A
Completed NCT00650091 - Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF Phase 3
Active, not recruiting NCT00258544 - Microarray Analysis of Gene Expression in Idiopathic Pulmonary Fibrosis (IPF)
Enrolling by invitation NCT04930289 - Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
Completed NCT02055222 - Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
Enrolling by invitation NCT06327360 - Illness Expectations in Pulmonary Fibrosis