IPF Longitudinal Natural History Study

NCT07560189 | Active Not Recruiting

• 1 other identifier: 2025-23-4
• Study Type: observational
• Target: 1,423
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

idiopathic pulmonary fibrosis; IPF; natural history; longitudinal cohort; disease progression; pulmonary fibrosis; mortality; acute exacerbation; hospitalization

Outcome Measures

Primary Outcomes (1)

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

  Time from cohort entry (baseline enrollment) to the first occurrence of any of the following events: acute exacerbation of idiopathic pulmonary fibrosis, respiratory-related hospitalization, or all-cause mortality. Events are prospectively recorded during longitudinal follow-up within the study period.

  24 months

Secondary Outcomes (5)

• Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis

  Up to 24 months

• Time to First Respiratory-Related Hospitalization

  Up to 24 months

• All-Cause Mortality

  Up to 24 months

• Inflammatory Burnout Index (IBI)-Defined Disease Activity

  Up to 12 months

• Severity-Phenotype-Dynamics (SPD) Integrated Disease States

  Up to 24 months

Study Arms (1)

Idiopathic Pulmonary Fibrosis Cohort

This cohort includes adult patients with idiopathic pulmonary fibrosis enrolled in a longitudinal observational study conducted between 2022 and 2026 at Assiut University. Participants undergo predefined follow-up assessments to document clinical outcomes, including disease progression, acute exacerbations, hospitalization, and mortality. No interventions are assigned, and all data are collected as part of routine clinical care and structured observational follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with idiopathic pulmonary fibrosis enrolled in a longitudinal observational cohort at Assiut University between 2022 and 2026. Participants undergo standardized baseline evaluation and structured follow-up to document disease progression, acute exacerbations, hospitalization, and mortality. The cohort represents real-world clinical practice and includes patients eligible for longitudinal assessment without intervention assignment.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty Of Medicine - Assiut University Hospitals - Assiut - Egypt

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Disease Progression; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmad M. shaddad, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Aliae A. Hussien, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Maiada K. Hashem, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: April 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)