Active — Not RecruitingNot Applicable

IPF Longitudinal Natural History Study

Egypt1,423 participantsStarted 2022-04-01

Plain-language summary

This is a longitudinal observational cohort study of patients with idiopathic pulmonary fibrosis (IPF) conducted within the Assiut University IPF Research Program between 2022 and 2026. The study aims to characterize the natural history, temporal disease dynamics, event patterns, and clinical outcomes of IPF over a two-year follow-up period. Primary analyses focus on disease progression, acute exacerbation, hospitalization, mortality, and final clinical state. Secondary analyses include prespecified evaluation of the Inflammatory Burnout Index (IBI; Zenodo DOI: 10.5281/zenodo.18843181) and the Severity-Phenotype-Dynamics integration framework (SPD; Zenodo DOI: 10.5281/zenodo.18843362) as observational analytical frameworks for disease activity and multidimensional disease characterization. These frameworks are applied for research stratification only and do not influence treatment allocation, clinical management, or follow-up decisions.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Adults aged ≥18 years. * Diagnosis of idiopathic pulmonary fibrosis based on clinical and radiological assessment according to standard guidelines. * Availability of baseline clinical, functional, and radiological evaluation. * Enrollment within the Assiut University IPF Research Program. * Ability to undergo longitudinal follow-up and outcome assessment. Exclusion Criteria: * Interstitial lung disease other than idiopathic pulmonary fibrosis * Alternative diagnosis inconsistent with IPF based on clinical or radiological evaluation * Incomplete baseline data preventing cohort classification * Refusal to participate or inability to complete follow-up * End-stage disease at baseline requiring invasive mechanical ventilation or terminal care * Active malignancy or severe comorbidity expected to dominate short-term prognosis * Long-term systemic immunosuppressive therapy not aligned with standard IPF management

What they're measuring

Time to First Composite Clinical Event (Acute Exacerbation, Hospitalization, or Death) in 24 months

Timeframe: 24 months

Trial details

NCT IDNCT07560189

SponsorAssiut University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-01