Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases.

NCT07577115 — Active not recruiting, 1000 participants, Istituto Clinico Humanitas

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

RegistryNCT07577115, acronym OCEAN-ILD
StatusActive not recruiting
Study typeObservational
Enrollment1000 (Estimated)
SponsorIstituto Clinico Humanitas (Other); collaborators: University of Padova, Azienda Ospedaliera Universitaria Senese
ConditionsInterstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder), Exposure Occupational, Occupational Exposure, Exposure to Household Air Pollution, Exposure to Chemical Pollution, Occupational, Exposure to Environmental Pollution, Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis, Hypersensitivity Pneumonitis, ILD Progression and Exposure to Indoor Environnemental Risk, ILD Progression and Exposure to Outdoor Polluants, ILD
Interventionsstandard interview (Other)
Datesstart 2026-04-01, primary completion 2034-12-01 (estimated), completion 2034-12-01 (estimated), first posted 2026-05-11, last updated 2026-05-11
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Interstitial Lung Disease Due to Systemic Disease (Disorder) All trials for Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder) All trials of standard interview

-Summary

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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
ILD Patients Undergoing Exposure AssessmentOther: standard interviewEligible 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.
  • standard interview (Other): standard interview to detect relevant exposures

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Humanitas research hospitalRozzano, ItalyItaly

+Publications

  • 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. PMID 28414524
  • 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. PMID 24429272
  • 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. PMID 33621598
  • 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. PMID 30578335
  • 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. PMID 30168753

+Investigators