Interstitial Lung DiseasesNCT07208201
Bronchoalveolar Lavage in Interstitial Lung Diseases to Characterization of Specific Inflammatory Cellular Infiltrate in Different Interstitial Lung Diseases
An observational study of Interstitial Lung Diseases, run by Maha Ahmed Abd EL Gawad Mohammed Okasha.
Trial summary
Interstitial lung disease (ILD) represents a various group of disorders characterized by inflammation and fibrosis within the lung parenchyma.[1] ILD refers to a group of diffuse parenchymal lung disorders, including a spectrum of conditions such as idiopathic pulmonary fibrosis (IPF), sarcoidosis, and connective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Diseases
- What is being tested?
- bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2025to 4 Dec 2027
- How long will I take part?
- 2 Years
- 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: subtypes of interstitial lung diseases
Who may be able to join
- Age ≥ 18 years
- Clinical suspicion of ILD based on symptoms, clinical examination, and radiological findings or newly diagnosed cases .
- HRCT findings consistent with ILD
- Willingness to undergo bronchoscopy with BAL and provide informed consent
Who cannot join
- Hemodynamic instability or ICU admission at time of evaluation
- Oxygen saturation < 88% on room air or < 92% on oxygen therapy
- Absolute contraindications to bronchoscopy (e.g., uncorrected bleeding diathesis, recent myocardial infarction)
- Associated chronic chest diseases other than ILD (COPD. bronchial asthma and lung cancer )
- Known active pulmonary infection or recent antibiotic treatment (< 2 weeks)
- Pregnancy
About this study
Official title: Clinical Utility of Bronchoalveolar Lavage in Interstitial Lung Diseases
Interstitial lung disease (ILD) represents a various group of disorders characterized by inflammation and fibrosis within the lung parenchyma.[1] ILD refers to a group of diffuse parenchymal lung disorders, including a spectrum of conditions such as idiopathic pulmonary fibrosis (IPF), sarcoidosis, and connective tissue disease-associated ILD (CTD-ILD) characterized by inflammation and fibrosis of the interstitium.
ILD results in Impaired lung function and, in severe cases, respiratory failure.[1] Diagnosing ILD is a complex task due to the heterogeneous nature of these disorders.
Read more
Distinguishing between different ILD subtypes and identifying disease progression present ongoing challenges in clinical practice. .[2] BAL emerges as a key investigative tool , allowing for the collection of bronchoalveolar fluid.
The cellular and molecular composition of BAL fluid provides valuable insights into the underlying pathology, aiding in the differential diagnosis of ILD subtypes.
The gold standard in BAL analysis is cytological examination by microscopy.[3] Flow cytometry is an updated method of BAL analysis which can provide quicker and more objective results and, with the appropriate design of antibody panels, accurately quantify the main leukocyte subsets.
Several studies have described the usefulness of flowcytometry for the discrimination of sarcoidosis from other lymphocytic pathologies or even to perform leukocyte subset counting in diverse ILDs.[4][5]
Both microscopic and flowcytometric examination of BAL in ILD are complementary tools that provide comprehensive information about the cellular landscape of the lower respiratory tract ,conclusive for:
Accurate diagnosis
Primary aim:
Characterization of specific inflammatory cellular infiltrate in different interstitial lung diseases.
- Secondary aims:
- Correlation between clinical ,radiological and inflammatory cellular pattern as regards BAL findings of different interstitial lung diseases
- Assessment of impact on outcome, prognosis and survival of the disease as regards management modification after BAL characterization
- Conditions
- Interstitial Lung Diseases
- Being tested
- bronchoscopy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopyProcedure or surgery
BAL is performed with the fiberoptic bronchoscope in a wedge position within the selected bronchopulmonary segment.
The total instilled volume of normal saline should be no less than 100 ml and should not exceed 300 ml.
Three to five sequentially instilled aliquots are generally withdrawn after each aliquot instillation.
For optimal sampling of distal airspaces, the total volume (pooled aliquots) retrieved should be greater than or equal to 30% of the total instilled volume.
A total volume of retrieved fluid less than 30% may provide a misleading cell differential, especially if total retrieved volume is less than 10% of total instilled volume.
If less than 5% of each instilled aliquot volume is recovered during the procedure due to retention of most of the fluid in the lavaged segment, the procedure should be aborted to avoid increased risk of tissue disruption and/or inflammatory mediator release due to overdistention of the lavaged segment.
What is being measured
The primary outcome is the main question the study is designed to answer.
description of pattern and percentage of specific inflammatory cellular infiltrate in different interstitial lung diseases in bronchoalveolar lavage .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start4 Dec 2025 (estimated)
- Primary completion4 Dec 2026 (estimated)
- Study completion4 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Maha Ahmed Abd EL Gawad Mohammed Okasha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maha Ahmed Abd EL Gawad Mohammed Okasha, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208201
- Sponsor's protocol ID
- BAL in ILD
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Bronchoalveolar Lavage in Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT07208201
- Acronym / sponsor ID
- BAL in ILD
- Conditions
- Interstitial Lung Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Maha Ahmed Abd EL Gawad Mohammed OkashaUniversity, hospital or other
- Study start
- 4 Dec 2025 (estimated)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 4 Dec 2027 (estimated)
- First posted
- 6 Oct 2025 (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.
Interstitial lung disease (ILD) represents a various group of disorders characterized by inflammation and fibrosis within the lung parenchyma.[1] ILD refers to a group of diffuse parenchymal lung disorders, including a spectrum of conditions such as idiopathic pulmonary fibrosis (IPF), sarcoidosis, and connective tissue disease-associated ILD (CTD-ILD) characterized by inflammation and fibrosis of the interstitium.
ILD results in Impaired lung function and, in severe cases, respiratory failure.[1] Diagnosing ILD is a complex task due to the heterogeneous nature of these disorders.
Distinguishing between different ILD subtypes and identifying disease progression present ongoing challenges in clinical practice. .[2] BAL emerges as a key investigative tool , allowing for the collection of bronchoalveolar fluid.
The cellular and molecular composition of BAL fluid provides valuable insights into the underlying pathology, aiding in the differential diagnosis of ILD subtypes.
The gold standard in BAL analysis is cytological examination by microscopy.[3] Flow cytometry is an updated method of BAL analysis which can provide quicker and more objective results and, with the appropriate design of antibody panels, accurately quantify the main leukocyte subsets.
Several studies have described the usefulness of flowcytometry for the discrimination of sarcoidosis from other lymphocytic pathologies or even to perform leukocyte subset counting in diverse ILDs.[4][5]
Both microscopic and flowcytometric examination of BAL in ILD are complementary tools that provide comprehensive information about the cellular landscape of the lower respiratory tract ,conclusive for:
Accurate diagnosis
Primary aim:
Characterization of specific inflammatory cellular infiltrate in different interstitial lung diseases.
- Secondary aims:
- Correlation between clinical ,radiological and inflammatory cellular pattern as regards BAL findings of different interstitial lung diseases
- Assessment of impact on outcome, prognosis and survival of the disease as regards management modification after BAL characterization
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subtypes of interstitial lung diseases
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Clinical suspicion of ILD based on symptoms, clinical examination, and radiological findings or newly diagnosed cases .
- HRCT findings consistent with ILD
- Willingness to undergo bronchoscopy with BAL and provide informed consent
Key exclusion criteria (6 listed)
- Hemodynamic instability or ICU admission at time of evaluation
- Oxygen saturation < 88% on room air or < 92% on oxygen therapy
- Absolute contraindications to bronchoscopy (e.g., uncorrected bleeding diathesis, recent myocardial infarction)
- Associated chronic chest diseases other than ILD (COPD. bronchial asthma and lung cancer )
- Known active pulmonary infection or recent antibiotic treatment (< 2 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopyBAL is performed with the fiberoptic bronchoscope in a wedge position within the selected bronchopulmonary segment. The total instilled volume of normal saline should be no less than 100 ml and should not exceed 300 ml. Three to five sequentially instilled aliquots are generally withdrawn after each aliquot instillation. For optimal sampling of distal airspaces, the total volume (pooled aliquots) retrieved should be greater than or equal to 30% of the total instilled volume. A total volume of retrieved fluid less than 30% may provide a misleading cell differential, especially if total retrieved volume is less than 10% of total instilled volume. If less than 5% of each instilled aliquot volume is recovered during the procedure due to retention of most of the fluid in the lavaged segment, the procedure should be aborted to avoid increased risk of tissue disruption and/or inflammatory mediator release due to overdistention of the lavaged segment. | Procedure or surgery | – |
Primary outcome
description of pattern and percentage of specific inflammatory cellular infiltrate in different interstitial lung diseases in bronchoalveolar lavage .
Time frame: 2 years
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 6 Oct 2025.
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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 Interstitial Lung Diseases, run by Maha Ahmed Abd EL Gawad Mohammed Okasha.
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 4 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 6 Oct 2025. 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?
description of pattern and percentage of specific inflammatory cellular infiltrate in different interstitial lung diseases in bronchoalveolar lavage . (time frame: 2 years). 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 6 Oct 2025.