Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases. (OCEAN-ILD)

Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases: a Prospective Observational Study.

The OCEAN-ILD study is designed to prospectively evaluate the prevalence and clinical relevance of environmental and occupational exposures in a large Italian cohort of patients affected by any ILD, using a standardised exposure questionnaire applied across multiple centres.

Study Overview

• Status: Active, not recruiting
• Conditions: Occupational Exposure; Hypersensitivity Pneumonitis; Exposure to Environmental Pollution; Idiopathic Pulmonary Fibrosis (IPF); ILD; Interstitial Lung Disease Due to Systemic Disease (Disorder); Progressive Pulmonary Fibrosis; Exposure Occupational; Exposure to Chemical Pollution, Occupational; Exposure to Household Air Pollution; Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder); ILD Progression and Exposure to Indoor Environnemental Risk; ILD Progression and Exposure to Outdoor Polluants
• Intervention / Treatment: Other: standard interview

Detailed Description

Interstitial lung diseases (ILDs) represent a diverse group of parenchymal lung disorders associated with significant morbidity and mortality, with few FDA-approved treatment options available. While certain subtypes-such as hypersensitivity pneumonitis and pneumoconiosis-are clearly linked to environmental exposures, the role of such exposures in other ILD forms remains less well defined. Recent evidence has showed that most patients across all types of ILD had potentially relevant inhalational exposures. Exposures were associated with worse transplant-free survival. Thus, identification and avoidance of exposures represent actionable targets in ILD management.

Different questionnaires have been proposed to evaluate occupational and environmental exposure in such patients. However, to date, there aren't standardized and validated questionnaires addressing exposures in patients with ILD. Interstitial lung diseases (ILDs) represent a diverse group of parenchymal lung disorders associated with significant morbidity and mortality, with few FDA-approved treatment options available. While certain subtypes-such as hypersensitivity pneumonitis and pneumoconiosis-are clearly linked to environmental exposures, the role of such exposures in other ILD forms remains less well defined. Recent evidence has showed that most patients across all types of ILD had potentially relevant inhalational exposures. Exposures were associated with worse transplant-free survival. Thus, identification and avoidance of exposures represent actionable targets in ILD management.

Different questionnaires have been proposed to evaluate occupational and environmental exposure in such patients. However, to date, there aren't standardized and validated questionnaires addressing exposures in patients with ILD. Moreover, frequency of exposure across different types of ILDs are not well defined in Italy.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Rozzano, Italy, Italy, 20089
      • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be identified during routine ILD outpatient visits and enrolled after written informed consent. Baseline data collection will occur at the time of enrollment.

Diagnostic consistency will be ensured through multidisciplinary discussion (MDD). The contribution of exposure history to diagnostic refinement and additional testing will be systematically recorded.

Data will be prospectively collected using a standardised CRF at baseline and every 6 months (±2 months), in line with clinical practice.

A structured questionnaire assessing environmental and occupational exposures will be:

• Administered at baseline
• Re-administered at each follow-up visit

Exposure domains will include:

• Occupational exposures (dusts, fibres, chemicals)
• Domestic exposures (mould, animals, biomass)
• Hobbies and recreational exposures
• Drug-related exposures Exposure relevance will be evaluated during MDD.

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Any gender
• Any race
• Ability to give informed consent according to ICH/EU GCP, and national/local regulations.
• New diagnosis of ILD according to classified according to American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias

Exclusion Criteria:

• Sarcoidosis
• Primary diagnosis of COPD and/or Asthma

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ILD Patients Undergoing Exposure Assessment; Eligible participants will be adults (≥18 years) with new diagnosis of ILD according to classified according to American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias.	Other: standard interview; standard interview to detect relevant exposures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of any exposure (environmental and/or occupational) in ILD patients.	to assess the frequency of environmental and/or occupational exposures among patients with newly diagnosed ILD	5 years
Use of a standardized questionnaire in all the centers	To standardise exposure assessment through a structured questionnaire across participating centres	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of environmental and/or occupational exposures in patients diagnosed with IPF, HP or other forms of ILD	To compare the frequency of any exposure among patients with idiopathic pulmonary fibrosis (IPF), hypersensitivity pneumonitis (HP), and other forms of ILD	5 years
All-cause mortality	All-cause mortality	5 years
Development of a progressive pulmonary fibrosis (PPF) phenotype.	To evaluate the percentage of patients developing a progressive pulmonary fibrosis (PPF) phenotype in the "exposure" and "no exposure" group.	5 years

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: University of Padova; Azienda Ospedaliera Universitaria Senese
• Investigators: Principal Investigator: Francesco Amati, MD, Humanitas Research Hospital IRCCS, Rozzano-Milan

Publications and helpful links

General Publications

• Cottin V, Hirani NA, Hotchkin DL, Nambiar AM, Ogura T, Otaola M, Skowasch D, Park JS, Poonyagariyagorn HK, Wuyts W, Wells AU. Presentation, diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases. Eur Respir Rev. 2018 Dec 21;27(150):180076. doi: 10.1183/16000617.0076-2018. Print 2018 Dec 31.
• Raghu G, Remy-Jardin M, Myers JL, Richeldi L, Ryerson CJ, Lederer DJ, Behr J, Cottin V, Danoff SK, Morell F, Flaherty KR, Wells A, Martinez FJ, Azuma A, Bice TJ, Bouros D, Brown KK, Collard HR, Duggal A, Galvin L, Inoue Y, Jenkins RG, Johkoh T, Kazerooni EA, Kitaichi M, Knight SL, Mansour G, Nicholson AG, Pipavath SNJ, Buendia-Roldan I, Selman M, Travis WD, Walsh S, Wilson KC; American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 1;198(5):e44-e68. doi: 10.1164/rccm.201807-1255ST.
• Ryerson CJ, Corte TJ, Lee JS, Richeldi L, Walsh SLF, Myers JL, Behr J, Cottin V, Danoff SK, Flaherty KR, Lederer DJ, Lynch DA, Martinez FJ, Raghu G, Travis WD, Udwadia Z, Wells AU, Collard HR. A Standardized Diagnostic Ontology for Fibrotic Interstitial Lung Disease. An International Working Group Perspective. Am J Respir Crit Care Med. 2017 Nov 15;196(10):1249-1254. doi: 10.1164/rccm.201702-0400PP. No abstract available.
• Morell F, Villar A, Montero MA, Munoz X, Colby TV, Pipvath S, Cruz MJ, Raghu G. Chronic hypersensitivity pneumonitis in patients diagnosed with idiopathic pulmonary fibrosis: a prospective case-cohort study. Lancet Respir Med. 2013 Nov;1(9):685-94. doi: 10.1016/S2213-2600(13)70191-7. Epub 2013 Oct 21.
• Lee CT, Adegunsoye A, Chung JH, Ventura IB, Jablonski R, Montner S, Vij R, Hines SE, Strek ME. Characteristics and Prevalence of Domestic and Occupational Inhalational Exposures Across Interstitial Lung Diseases. Chest. 2021 Jul;160(1):209-218. doi: 10.1016/j.chest.2021.02.026. Epub 2021 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ILD; Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Occupational Exposure; extrinsic allergic alveolitis; Progressive Pulmonary Fibrosis; Exposure to Environmental Pollution; Exposure to Chemical Pollution, Occupational; Exposure to household air pollution; Hypersensitivity pneumonitis; chronic hypersensitivity pneumonitis; acute hypersensitivity pneumonitis
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Alveolitis, Extrinsic Allergic
• Other Study ID Numbers: Prot. Nr. 57/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No