Idiopathic Pulmonary FibrosisNCT07783230
Blood Cell Count Derived Inflammatory Indexes in Acute Exacerbation of Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis and Acute Exacerbation of Idiopathic Pulmonary Fibrosis, run by Assiut University.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease characterized by progressive scarring. Sometimes, patients experience a sudden and severe worsening of their symptoms, known as an acute exacerbation (AE-IPF), which carries a high risk of mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Acute Exacerbation of Idiopathic Pulmonary Fibrosis
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2027
- 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
- Adult, Older adult
Study population: The study population consists of adult patients (18 years of age or older) with an established diagnosis of idiopathic pulmonary fibrosis (IPF) who are admitted to a tertiary referral center (Assiut University Hospitals) for an acute exacerbation of IPF within 72 hours of symptomatic worsening.
Who may be able to join
- Age 18 years or older.
- Established diagnosis of idiopathic pulmonary fibrosis per the 2023 ATS/ERS/JRS/ALAT clinical practice guideline, based on a multidisciplinary assessment incorporating clinical features, high-resolution computed tomography pattern, and, where available, surgical lung biopsy.
- Hospital admission for acute exacerbation of IPF meeting the 2016 International Working Group criteria: previous or concurrent IPF diagnosis; acute worsening or development of dyspnea of less than one month duration; computed tomography showing new bilateral ground-glass abnormality or consolidation superimposed on a background pattern of usual interstitial pneumonia; deterioration not fully explained by cardiac failure or fluid overload and triggered exacerbations would be included.
- Admission within 72 hours of symptomatic worsening.
- Written informed consent from the patient or legally authorized representative.
Who cannot join
- Alternative explanation for acute respiratory deterioration confirmed at or shortly after admission, including but not limited to microbiologically confirmed bacterial pneumonia with positive blood or respiratory culture, computed-tomography-confirmed pulmonary embolism, cardiogenic pulmonary edema with elevated brain natriuretic peptide and supportive echocardiographic findings, or pneumothorax.
- Interstitial lung disease attributable to a defined cause: connective-tissue-disease-associated ILD, chronic hypersensitivity pneumonitis, occupational pneumoconiosis, sarcoidosis, or drug-induced ILD.
- Active solid or hematologic malignancy, including any malignancy under active treatment within the preceding 12 months.
- Receipt of cytotoxic chemotherapy, radiotherapy, or non-IPF immunosuppressive therapy (excluding maintenance corticosteroid at prednisolone-equivalent $\le$ 10 mg daily) within the preceding 30 days.
- Primary hematologic disorder altering the complete blood count, including leukemia, lymphoma, myelodysplastic syndrome, aplastic anemia, or known immune-mediated cytopenia.
- Anticipated transfer to another facility within 72 hours of admission.
About this study
Official title: Dynamic Blood Cell Count Derived Inflammatory Indexes as a Biomarker in Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease characterized by progressive scarring. Sometimes, patients experience a sudden and severe worsening of their symptoms, known as an acute exacerbation (AE-IPF), which carries a high risk of mortality. Currently, doctors lack reliable bedside tools at the time of hospital admission to predict which patients will improve with standard care and which will require early escalation of treatment.
This prospective observational study aims to determine if simple, widely available blood tests can be used as biomarkers to predict patient outcomes during an acute exacerbation. Researchers will focus on complete blood count (CBC)-derived inflammatory indexes, which are calculated ratios of different types of blood cells (such as the neutrophil-to-lymphocyte ratio).
Read more
Participants hospitalized with AE-IPF will have their blood cell counts and oxygen levels (PaO2/FiO2 ratio) monitored on days 0 (admission), 3, 7, and 14. The study will evaluate the correlation between the change in these inflammatory indexes and the change in oxygen levels over the first week of hospitalization. Additionally, it will assess how accurately the admission blood test values, compared to the changes seen by day 3, can predict in-hospital clinical deterioration (such as the need for a ventilator, transfer to the intensive care unit, or death).
The aim is to find out if tracking changes in these simple blood test indexes can provide clinicians with a cost-effective, early-warning tool to guide treatment decisions for patients suffering from AE-IPF.
Read the detailed description
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrosing interstitial pneumonia of unknown cause carrying a median survival of approximately three years from diagnosis. While most patients experience gradual functional deterioration, a substantial subset suffers acute exacerbations (AE-IPF) characterized by rapid worsening of dyspnea, new bilateral ground-glass opacities or consolidation on imaging, and severe hypoxemia. AE-IPF carries an in-hospital mortality of 50% or higher, and clinicians currently lack reliable bedside tools to predict which patients will improve with conservative therapy and who will require early escalation.
The complete blood count (CBC) is a widely available and inexpensive laboratory test. Mathematically derived ratios and composite indices (such as the neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], platelet-to-lymphocyte ratio [PLR], and systemic immune-inflammation index [SII]) reflect the balance of innate and adaptive immunity and have been associated with adverse outcomes across various inflammatory and neoplastic conditions. However, most CBC-index work in IPF has examined stable-state prognostication or static admission values. This study addresses a substantive gap in the literature by systematically characterizing the dynamic behavior of these indices in response to AE-IPF treatment, utilizing head-to-head paired comparisons of baseline versus on-treatment change values.
This prospective, single-centre observational cohort study will be conducted at Assiut University Hospitals. Enrolled patients will undergo a full medical and clinical history, clinical examination, and a high-resolution computed tomography (HRCT) review to re-confirm the underlying usual interstitial pneumonia (UIP) pattern.
Key assessments include:
- CBC Monitoring: Assessed at days 0, 3, 7, and 14 (if hospitalized) to track absolute cell counts and calculate derived inflammatory indices (NLR, MLR, PLR, SII, SIRI, AISI, and PIV).
- Arterial Blood Gas (ABG): Assessed on stable FiO2 to track the PaO2/FiO2 ratio from day 0 to day 7.
- GAP Index: Calculated using the most recent stable-state pulmonary function values (incorporating gender, age, and physiology) whenever possible.
- Clinical Monitoring:Treatment exposures (steroids, antibiotics, antifibrotics), adverse events, and escalations to ventilatory support will be recorded.
- Keywords
- Idiopathic Pulmonary Fibrosis, Acute Exacerbation, Complete Blood Count, Biomarkers, Inflammatory Indexes, Neutrophil-to-Lymphocyte Ratio
- Medical subject headings
- Idiopathic 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 |
|---|---|---|
| Hospitalized AE-IPF Cohort | Adult patients (18 years or older) with an established diagnosis of Idiopathic Pulmonary Fibrosis (IPF) admitted to the hospital for an acute exacerbation of IPF (AE-IPF) within 72 hours of symptomatic worsening. The cohort will be observed for changes in complete blood count (CBC)-derived inflammatory indices (such as NLR, MLR, PLR, SII, SIRI, AISI, and PIV) and PaO2/FiO2 ratio over a specified interval (days 0, 3, 7, and 14). Standard treatment exposures, including steroids, antibiotics, and antifibrotics, will also be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2)
The PaO2/FiO2 ratio assesses hypoxemia and lung function. The outcome is the absolute change in this ratio, calculated as: (PaO2/FiO2 on day 7) - (PaO2/FiO2 on day 0). For patients who die before day 7, the worst (lowest) PaO2/FiO2 value recorded prior to death is used as the day-7 value. For patients discharged before day 7, the value on the day of discharge is carried forward.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Alaa Eldeen Salah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783230
- Sponsor's protocol ID
- Inflammatory Indexes in AE-IPF
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Blood Cell Count Derived Inflammatory Indexes as a Biomarker in Acute Exacerbation of Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07783230
- Acronym / sponsor ID
- Inflammatory Indexes in AE-IPF
- Keywords
- Idiopathic Pulmonary Fibrosis, Acute Exacerbation, Complete Blood Count, Biomarkers, Inflammatory Indexes, Neutrophil-to-Lymphocyte Ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Aug 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.
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease characterized by progressive scarring. Sometimes, patients experience a sudden and severe worsening of their symptoms, known as an acute exacerbation (AE-IPF), which carries a high risk of mortality. Currently, doctors lack reliable bedside tools at the time of hospital admission to predict which patients will improve with standard care and which will require early escalation of treatment.
This prospective observational study aims to determine if simple, widely available blood tests can be used as biomarkers to predict patient outcomes during an acute exacerbation. Researchers will focus on complete blood count (CBC)-derived inflammatory indexes, which are calculated ratios of different types of blood cells (such as the neutrophil-to-lymphocyte ratio).
Participants hospitalized with AE-IPF will have their blood cell counts and oxygen levels (PaO2/FiO2 ratio) monitored on days 0 (admission), 3, 7, and 14. The study will evaluate the correlation between the change in these inflammatory indexes and the change in oxygen levels over the first week of hospitalization. Additionally, it will assess how accurately the admission blood test values, compared to the changes seen by day 3, can predict in-hospital clinical deterioration (such as the need for a ventilator, transfer to the intensive care unit, or death).
The aim is to find out if tracking changes in these simple blood test indexes can provide clinicians with a cost-effective, early-warning tool to guide treatment decisions for patients suffering from AE-IPF.
Detailed description
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrosing interstitial pneumonia of unknown cause carrying a median survival of approximately three years from diagnosis. While most patients experience gradual functional deterioration, a substantial subset suffers acute exacerbations (AE-IPF) characterized by rapid worsening of dyspnea, new bilateral ground-glass opacities or consolidation on imaging, and severe hypoxemia. AE-IPF carries an in-hospital mortality of 50% or higher, and clinicians currently lack reliable bedside tools to predict which patients will improve with conservative therapy and who will require early escalation.
The complete blood count (CBC) is a widely available and inexpensive laboratory test. Mathematically derived ratios and composite indices (such as the neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], platelet-to-lymphocyte ratio [PLR], and systemic immune-inflammation index [SII]) reflect the balance of innate and adaptive immunity and have been associated with adverse outcomes across various inflammatory and neoplastic conditions. However, most CBC-index work in IPF has examined stable-state prognostication or static admission values. This study addresses a substantive gap in the literature by systematically characterizing the dynamic behavior of these indices in response to AE-IPF treatment, utilizing head-to-head paired comparisons of baseline versus on-treatment change values.
This prospective, single-centre observational cohort study will be conducted at Assiut University Hospitals. Enrolled patients will undergo a full medical and clinical history, clinical examination, and a high-resolution computed tomography (HRCT) review to re-confirm the underlying usual interstitial pneumonia (UIP) pattern.
Key assessments include:
- CBC Monitoring: Assessed at days 0, 3, 7, and 14 (if hospitalized) to track absolute cell counts and calculate derived inflammatory indices (NLR, MLR, PLR, SII, SIRI, AISI, and PIV).
- Arterial Blood Gas (ABG): Assessed on stable FiO2 to track the PaO2/FiO2 ratio from day 0 to day 7.
- GAP Index: Calculated using the most recent stable-state pulmonary function values (incorporating gender, age, and physiology) whenever possible.
- Clinical Monitoring:Treatment exposures (steroids, antibiotics, antifibrotics), adverse events, and escalations to ventilatory support will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized AE-IPF Cohort | – | –Adult patients (18 years or older) with an established diagnosis of Idiopathic Pulmonary Fibrosis (IPF) admitted to the hospital for an acute exacerbation of IPF (AE-IPF) within 72 hours of symptomatic worsening. The cohort will be observed for changes in complete blood count (CBC)-derived inflammatory indices (such as NLR, MLR, PLR, SII, SIRI, AISI, and PIV) and PaO2/FiO2 ratio over a specified interval (days 0, 3, 7, and 14). Standard treatment exposures, including steroids, antibiotics, and antifibrotics, will also be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (18 years of age or older) with an established diagnosis of idiopathic pulmonary fibrosis (IPF) who are admitted to a tertiary referral center (Assiut University Hospitals) for an acute exacerbation of IPF within 72 hours of symptomatic worsening.
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Established diagnosis of idiopathic pulmonary fibrosis per the 2023 ATS/ERS/JRS/ALAT clinical practice guideline, based on a multidisciplinary assessment incorporating clinical features, high-resolution computed tomography pattern, and, where available, surgical lung biopsy.
- Hospital admission for acute exacerbation of IPF meeting the 2016 International Working Group criteria: previous or concurrent IPF diagnosis; acute worsening or development of dyspnea of less than one month duration; computed tomography showing new bilateral ground-glass abnormality or consolidation superimposed on a background pattern of usual interstitial pneumonia; deterioration not fully explained by cardiac failure or fluid overload and triggered exacerbations would be included.
- Admission within 72 hours of symptomatic worsening.
- Written informed consent from the patient or legally authorized representative.
Key exclusion criteria (6 listed)
- Alternative explanation for acute respiratory deterioration confirmed at or shortly after admission, including but not limited to microbiologically confirmed bacterial pneumonia with positive blood or respiratory culture, computed-tomography-confirmed pulmonary embolism, cardiogenic pulmonary edema with elevated brain natriuretic peptide and supportive echocardiographic findings, or pneumothorax.
- Interstitial lung disease attributable to a defined cause: connective-tissue-disease-associated ILD, chronic hypersensitivity pneumonitis, occupational pneumoconiosis, sarcoidosis, or drug-induced ILD.
- Active solid or hematologic malignancy, including any malignancy under active treatment within the preceding 12 months.
- Receipt of cytotoxic chemotherapy, radiotherapy, or non-IPF immunosuppressive therapy (excluding maintenance corticosteroid at prednisolone-equivalent $\le$ 10 mg daily) within the preceding 30 days.
- Primary hematologic disorder altering the complete blood count, including leukemia, lymphoma, myelodysplastic syndrome, aplastic anemia, or known immune-mediated cytopenia.
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
Change in Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2)
Time frame: Baseline
The PaO2/FiO2 ratio assesses hypoxemia and lung function. The outcome is the absolute change in this ratio, calculated as: (PaO2/FiO2 on day 7) - (PaO2/FiO2 on day 0). For patients who die before day 7, the worst (lowest) PaO2/FiO2 value recorded prior to death is used as the day-7 value. For patients discharged before day 7, the value on the day of discharge is carried forward.
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 24 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Acute Exacerbation of Idiopathic Pulmonary Fibrosis, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2) (time frame: Baseline). 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 24 Aug 2026.