Idiopathic Pulmonary Fibrosis (IPF)NCT07560189
IPF Longitudinal Natural History Study
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- How many people
- 1,423 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty Of Medicine - Assiut University Hospitals - Assiut - Egypt
Asyut, 71515
About this study
Official title: Natural History and Temporal Dynamics of Idiopathic Pulmonary Fibrosis: A Longitudinal Cohort Study With Structured Disease Stratification
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.
Read the detailed description
This observational cohort study follows patients with idiopathic pulmonary fibrosis using predefined longitudinal clinical, physiological, radiological, and outcome assessments. The study is designed to describe disease burden, temporal progression, event distribution, and end-state outcomes in a real-world IPF cohort.
Eligible participants are adults with a clinical and radiological diagnosis of IPF according to standard diagnostic assessment, with available baseline evaluation and planned longitudinal follow-up. Patients are followed for up to two years to document acute exacerbations, respiratory hospitalization, functional decline, mortality, and final clinical status.
The study includes secondary analytical evaluation of two predefined disease-characterization frameworks. The Inflammatory Burnout Index (IBI) is used to evaluate dynamic inflammatory-fibrotic balance and functional reserve. The SPD framework integrates disease severity, phenotype, and dynamic disease behavior into a multidimensional observational stratification structure. Both frameworks are archived with Zenodo DOIs and are evaluated without modifying patient care.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- idiopathic pulmonary fibrosis, IPF, natural history, longitudinal cohort, disease progression, pulmonary fibrosis, mortality, acute exacerbation, hospitalization
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Disease Progression, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (5)
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Time from baseline enrollment to the first occurrence of acute exacerbation of idiopathic pulmonary fibrosis during follow-up.
Measured: Up to 24 months
Time to First Respiratory-Related Hospitalization
Time from baseline to first hospitalization related to respiratory deterioration or acute exacerbation.
Measured: Up to 24 months
All-Cause Mortality
Occurrence of death from any cause during the study follow-up period.
Measured: Up to 24 months
Inflammatory Burnout Index (IBI)-Defined Disease Activity
Evaluation of disease activity using the Inflammatory Burnout Index (IBI), a predefined analytical framework for dynamic disease characterization (Zenodo DOI: 10.5281/zenodo.18843181). Applied observationally without influencing clinical management.
Measured: Up to 12 months
Severity-Phenotype-Dynamics (SPD) Integrated Disease States
Assessment of integrated disease states using the Severity-Phenotype-Dynamics (SPD) framework combining severity, phenotype, and dynamic disease behavior (Zenodo DOI: 10.5281/zenodo.18843362). Applied for observational stratification only.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Apr 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Shaddad, Assiut University
- Investigators
- Ahmad M. shaddad, MD, Principal investigator, Assiut UniversityAliae A. Hussien, MD, Principal investigator, Assiut UniversityMaiada K. Hashem, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560189
- Sponsor's protocol ID
- 2025-23-4
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data underlying the results reported in this study will not be publicly shared. Data are governed by the Assiut University IPF Research Program policies and institutional regulations. De-identified data may be considered for sharing upon reasonable request to the corresponding investigator, subject to institutional review, ethical approval, and execution of a formal data use agreement. Analytical code and model specifications are not publicly distributed. Access may be considered under controlled conditions in accordance with institutional policy, intellectual property considerations, and approved collaborative agreements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Temporal Dynamics of Idiopathic Pulmonary Fibrosis: A Longitudinal Cohort Study With Structured Disease Stratification
- ClinicalTrials.gov ID
- NCT07560189
- Acronym / sponsor ID
- 2025-23-4
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- idiopathic pulmonary fibrosis, IPF, natural history, longitudinal cohort, disease progression, pulmonary fibrosis, mortality, acute exacerbation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,423 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This observational cohort study follows patients with idiopathic pulmonary fibrosis using predefined longitudinal clinical, physiological, radiological, and outcome assessments. The study is designed to describe disease burden, temporal progression, event distribution, and end-state outcomes in a real-world IPF cohort.
Eligible participants are adults with a clinical and radiological diagnosis of IPF according to standard diagnostic assessment, with available baseline evaluation and planned longitudinal follow-up. Patients are followed for up to two years to document acute exacerbations, respiratory hospitalization, functional decline, mortality, and final clinical status.
The study includes secondary analytical evaluation of two predefined disease-characterization frameworks. The Inflammatory Burnout Index (IBI) is used to evaluate dynamic inflammatory-fibrotic balance and functional reserve. The SPD framework integrates disease severity, phenotype, and dynamic disease behavior into a multidimensional observational stratification structure. Both frameworks are archived with Zenodo DOIs and are evaluated without modifying patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to First Composite Clinical Event (Acute Exacerbation, Hospitalization, or Death) in 24 months
Time frame: 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.
5 secondary outcomes
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Time frame: Up to 24 months
Time to First Respiratory-Related Hospitalization
Time frame: Up to 24 months
All-Cause Mortality
Time frame: Up to 24 months
Inflammatory Burnout Index (IBI)-Defined Disease Activity
Time frame: Up to 12 months
Severity-Phenotype-Dynamics (SPD) Integrated Disease States
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data underlying the results reported in this study will not be publicly shared. Data are governed by the Assiut University IPF Research Program policies and institutional regulations. De-identified data may be considered for sharing upon reasonable request to the corresponding investigator, subject to institutional review, ethical approval, and execution of a formal data use agreement. Analytical code and model specifications are not publicly distributed. Access may be considered under controlled conditions in accordance with institutional policy, intellectual property considerations, and approved collaborative agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad M. shaddad, MD principal investigator
Assiut University
Aliae A. Hussien, MD principal investigator
Assiut University
Maiada K. Hashem, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Composite Clinical Event (Acute Exacerbation, Hospitalization, or Death) in 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.