Novel Markers of Disease Progression in Interstitial Lung Disease

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05760508

Acronym

NOMAD

Enrollment

120

Registered

2023-03-08

Start date

2018-07-23

Completion date

2024-01-31

Last updated

2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

Brief summary

Study design: A prospective cohort study with a longitudinal design, with several parameters measured serially at baseline and at pre-specified time points during three to five years of clinical observation. Primary objective: To validate quantitative analysis of lung sounds as a marker of disease progression in a cohort of patients with Interstitial Lung Disease (ILD) via correlation with the extent of fibrosis on HRCT, measured both via visual scoring and quantitative CT assessment, and other validated parameters of disease progression such as FVC, tolerance to exercise and patient-related outcomes (symptoms and quality of life). Secondary objectives: To determine the prognostic value of quantitative analysis of lung sounds and a series of novel putative biological markers, obtained from peripheral blood and bronchoalveolar lavage, toward poor outcomes (death, categorical decline of % predicted FVC \>10%, acute exacerbation or respiratory-related hospitalisations) as compared to more conventional clinical, physiology and radiologic measurements.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

Inclusion criteria

* diagnosis of ILD, made according to international guidelines where available * age between 40 and 90 years

Exclusion criteria

* significant comorbidities or physical impairment that could affect participation

Design outcomes

Primary

Measure	Time frame	Description
Disease progression	3 years	Validate quantitative analysis of lung sounds as a marker of disease progression via correlation with the extent of fibrosis on HRCT, measured both via visual scoring and quantitative CT assessment, and other validated parameters of disease progression such as FVC, tolerance to exercise and patient-related outcomes.

Countries

Italy

Outcome results