Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07577115

Occupational and Environmental Exposures Analysis in Interstitial Lung Diseases.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Interstitial Lung Disease Due to Systemic Disease (Disorder) Alveolitis, Extrinsic Allergic Exposure Occupational Exposure to Chemical Pollution, Occupational Exposure to Environmental Pollution Exposure to Household Air Pollution Hypersensitivity Hypersensitivity Pneumonitis Hypersensitivity, Immediate ILD ILD Progression and Exposure to Indoor Environnemental Risk ILD Progression and Exposure to Outdoor Polluants Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF) Immune System Diseases Interstitial Lung Disease Due to Systemic Disease (Telomere Biology Disorder) Lung Diseases Lung Diseases, Interstitial Occupational Exposure Progressive Pulmonary Fibrosis Pulmonary Fibrosis Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas research hospital

Rozzano, Italy, 20089

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard interview

Other

standard interview to detect relevant exposures

Primary outcomes

  1. Frequency of any exposure (environmental and/or occupational) in ILD patients.

    Time frame: 5 years

    to assess the frequency of environmental and/or occupational exposures among patients with newly diagnosed ILD

  2. Use of a standardized questionnaire in all the centers

    Time frame: 5 years

    To standardise exposure assessment through a structured questionnaire across participating centres

Secondary outcomes

  1. The prevalence of environmental and/or occupational exposures in patients diagnosed with IPF, HP or other forms of ILD

    Time frame: 5 years

    To compare the frequency of any exposure among patients with idiopathic pulmonary fibrosis (IPF), hypersensitivity pneumonitis (HP), and other forms of ILD

  2. All-cause mortality

    Time frame: 5 years

    All-cause mortality

  3. Development of a progressive pulmonary fibrosis (PPF) phenotype.

    Time frame: 5 years

    To evaluate the percentage of patients developing a progressive pulmonary fibrosis (PPF) phenotype in the "exposure" and "no exposure" group.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Collaborators

  • Azienda Ospedaliera Universitaria Senese
  • University of Padova

Registry information

Official study title

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

Acronym: OCEAN-ILD

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.