Lung Diffusing Capacities Normality Thresholds in Pulmonary Fibrosis and Emphysema

NCT07091838 | Completed DMC

• 1 other identifier: Liguria: 59/2025 - id 14300
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators tested the usefulness of lung diffusing capacities for carbon monoxide (DLco) and nitric oxide (DLNO) normality thresholds of 5th and 2.5th percentiles for the assessment of intersitial pulmonary fibrosis (IPF) and pulmonary emphysema (PE). Computed tomography (CT) of the chest was taken as a gold standard for the presence of lung parenchymal abnormalities typical of these conditions. The investigators retrospectively utilized the DLco and DLNO data obtained by a single device in sixty-six subjects with IPF included in two previous studies and in fifty-four new subjects with PE, both documented by quantitative CT of the chest.

Conditions

Interstitial Pulmonary Fibrosis, Emphysema

Keywords

Lung diffusing capacity; Lower limit of normal; interstitial pulmonary fibrosis; pulmonary emphysema

Outcome Measures

Primary Outcomes (2)

• Lung diffusing capacities for carbon monoxide (DLco) and nitric oxide (DLNO) normality thresholds in IPF and emphysema

  "Baseline" or "Day 1"

• The receiver operating characteristics (ROC)-derived DLco and DLNO normality thresholds for the assessment of interstitial pulmonary fibrosis (IPF) and pulmonary emphysema (PE)

  DLco and DLNO thresholds may change depending on chosen reference equations, device, sex, and disease condition

  "Baseline" or "Day 1"

Study Arms (3)

Healthy control

Asymptomatic healthy subjects, selected among health professionals and their relatives

Interstitial Pulmonary Fibrosis (IPF)

Subjects from investigators' previous studies with interstitial pulmonary fibrosis (IPF), 43 due to usual or nonspecific interstitial pneumonia and 23 to systemic sclerosis

Subjects with a smoking history ≥10 pack-years and computed tomography-determined emphysema

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asymptomatic healthy controls with lung function parameters above the LLN5, i.e., -1.645 z-score. Moreover, subjects of white European ancestry with CT-determined IPF and/or PE

You may qualify if:

• Asymptomatic healthy controls with lung function parameters above the LLN5, i.e., -1.645 z-score
• Subjects of white European ancestry with CT-determined IPF and/or PE

You may not qualify if:

• All subjects with history of any comorbidities potentially affecting lung diffusing capacity, i.e., congestive heart failure, liver or kidney diseases, and morbid obesity

Sponsors & Collaborators

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: lead

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

Related Publications (2)

• Zavorsky GS, Hsia CC, Hughes JM, Borland CD, Guenard H, van der Lee I, Steenbruggen I, Naeije R, Cao J, Dinh-Xuan AT. Standardisation and application of the single-breath determination of nitric oxide uptake in the lung. Eur Respir J. 2017 Feb 8;49(2):1600962. doi: 10.1183/13993003.00962-2016. Print 2017 Feb.

  PMID: 28179436 BACKGROUND

• Barisione G, Stanojevic S, Brusasco V. Zone of z-scores uncertainty in pulmonary function interpretation: A proof-of-concept study from CO and NO lung diffusing capacities. Respir Med. 2026 Jan;251:108600. doi: 10.1016/j.rmed.2025.108600. Epub 2025 Dec 18.

  PMID: 41421563 DERIVED

MeSH Terms

Conditions

Pulmonary Fibrosis; Emphysema; Pulmonary Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory Pathophysiology Director

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 29, 2025
• Study Start: May 13, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 7, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 1 year after publication with no end date

Locations

IT (1)