NCT04864990

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

October 22, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

April 27, 2021

Last Update Submit

March 28, 2022

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evolution of dyspnea during activities of daily living

    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

    baseline, 6 months

  • Assess the prevalence of refractory dyspnea

    baseline, 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 patients with a diagnosis of idiopathic pulmonary fibrosis (IPF) and reporting dyspnea

You may qualify if:

  • diagnosis of IPF according to ATS/ERS guidelines
  • dyspnea at rest (VAS ≥ 1) or on exertion (mMRC ≥ 1)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Calmette Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cécile Chenivesse, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Chenivesse, MD,PhD

CONTACT

0320445962cecile.chenivesse@chru-lille.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 29, 2021

Study Start

October 22, 2021

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

FR(1)