An observational study in Idiopathic Pulmonary Fibrosis and Acute Exacerbation of Idiopathic Pulmonary Fibrosis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Assiut University · Observational
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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.
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:
577 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 124 are open to participants now.
This study's planned enrollment of 70 is below the median of 152 across 165 observational studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Baseline
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 74 non-industry observational studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 102. This study's planned 12 months is below that.
Counting every sponsor, half of 88 studies reached it within 51 months; a quarter within 29 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis →