AsbestosisNCT05133453
Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
A study testing Pirfenidone in people with Asbestosis, run by Cairo University.
Trial summary
This study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Asbestosis
- What is being tested?
- Pirfenidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged ≥ 18 years old
- Patients who fulfilled investigations according the study protocol.
- Patients who kept on follow up for the entire study.
- All patients fulfilling the clinical and radiological criteria of asbestosis (Existence of asbestos-specific pleural changes in high resolution computed topography HRCT (pleural plaques), Reticular changes in HRCT and restrictive lung function pattern, History of asbestos exposure, Absence of an alternative explanation for fibrotic lung disease )
- Clinically stable patients.
- Patients who signed informed consent
- Patients with mild-to-moderate IPF [forced vita capacity (FVC) ≥50% of predicted and diffusion capacity of carbon monoxide (DLCO) ≥30% of predicted].
- Duration since diagnosis (at least one year before the study)
Who cannot join
- Patients with peptic ulcer,
- Severe hepatic disease, hepatitis C infection or any of the following liver function test criteria above specified limits: aspartate or alanine aminotransferase (AST or ALT) >2.5 u above upper limit of normal level.
- Severe kidney disease, Cardiac disease, and Patients with other chronic pulmonary diseases, lung cancer
- Presence of coexisting respiratory infection
- History of alcohol or drugs abuse
- Patients with neuromuscular disease,
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- Chronic renal failure,
- Patient on oxygen therapy,
- Life expectancy less than 6 months,
- History of malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.
Read the detailed description
Asbestos exposure is associated with pleural and lung fibrosis and lung cancer. It has pathomechanisms and clinical similarities to interstitial pulmonary fibrosis disease. There is no definite cure for asbestosis. Pirfenidone has antifibrotic and anti-inflammatory effects.The safety and effectiveness of pirfenidone for the treatment of non-interstitial pulmonary fibrosis progressive fibrotic interstitial lung diseases remain unclear including asbestosis. Only few studies for pirfenidone use in asbestosis.
- Conditions
- Asbestosis
- Being tested
- Pirfenidone
- Keywords
- Pirfenidone, Asbestosis
- Medical subject headings
- Asbestosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Also called Conventional treatment
drug intake three times daily for one year
| Study group | Role | What they receive |
|---|---|---|
| Pirfinedone group | Active comparator | asbestosis patients given pirfenidone drug Receives: Drug: Pirfenidone |
| Conventional group | No intervention | Asbestosis patients on conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilatory function change
Absolute change in percent predicted forced vital capacity
Measured: after 6 months and 12 months from the start of the trial
Diffusion test
Diffusion test change from baseline
Measured: after 6 months and 12 months from the start of the trial
radiological findings change
radiological changes in High resolution computed topography.
Measured: after 6 months and 12 months from the start of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsbestosisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohammed Fouad, Cairo University
- Investigators
- Marwa M Fouad, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133453
- Sponsor's protocol ID
- Pirfenidone in asbestosis
- Status last verified
- Aug 2023
- First submitted
- 1 Nov 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Behr J, Prasse A, Kreuter M, Johow J, Rabe KF, Bonella F, Bonnet R, Grohe C, Held M, Wilkens H, Hammerl P, Koschel D, Blaas S, Wirtz H, Ficker JH, Neumeister W, Schonfeld N, Claussen M, Kneidinger N, Frankenberger M, Hummler S, Kahn N, Tello S, Freise J, Welte T, Neuser P, Gunther A; RELIEF investigators. Pirfenidone in patients with progressive fibrotic interstitial lung diseases other than idiopathic pulmonary fibrosis (RELIEF): a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Respir Med. 2021 May;9(5):476-486. doi: 10.1016/S2213-2600(20)30554-3. Epub 2021 Mar 30.
PubMed 33798455
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
- ClinicalTrials.gov ID
- NCT05133453
- Acronym / sponsor ID
- Pirfenidone in asbestosis
- Conditions
- Asbestosis
- Keywords
- Pirfenidone, Asbestosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Nov 2021 (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 study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.
Detailed description
Asbestos exposure is associated with pleural and lung fibrosis and lung cancer. It has pathomechanisms and clinical similarities to interstitial pulmonary fibrosis disease. There is no definite cure for asbestosis. Pirfenidone has antifibrotic and anti-inflammatory effects.The safety and effectiveness of pirfenidone for the treatment of non-interstitial pulmonary fibrosis progressive fibrotic interstitial lung diseases remain unclear including asbestosis. Only few studies for pirfenidone use in asbestosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfinedone group | Active comparator | Drug: Pirfenidoneasbestosis patients given pirfenidone drug |
| Conventional group | No intervention | –Asbestosis patients on conventional treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male patients aged ≥ 18 years old
- Patients who fulfilled investigations according the study protocol.
- Patients who kept on follow up for the entire study.
- All patients fulfilling the clinical and radiological criteria of asbestosis (Existence of asbestos-specific pleural changes in high resolution computed topography HRCT (pleural plaques), Reticular changes in HRCT and restrictive lung function pattern, History of asbestos exposure, Absence of an alternative explanation for fibrotic lung disease )
- Clinically stable patients.
Key exclusion criteria (10 listed)
- Patients with peptic ulcer,
- Severe hepatic disease, hepatitis C infection or any of the following liver function test criteria above specified limits: aspartate or alanine aminotransferase (AST or ALT) >2.5 u above upper limit of normal level.
- Severe kidney disease, Cardiac disease, and Patients with other chronic pulmonary diseases, lung cancer
- Presence of coexisting respiratory infection
- History of alcohol or drugs abuse
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 |
|---|---|---|
| PirfenidoneAlso: Conventional treatmentdrug intake three times daily for one year | Drug | Pirfinedone group |
Primary outcome
Ventilatory function change
Time frame: after 6 months and 12 months from the start of the trial
Absolute change in percent predicted forced vital capacity
Diffusion test
Time frame: after 6 months and 12 months from the start of the trial
Diffusion test change from baseline
radiological findings change
Time frame: after 6 months and 12 months from the start of the trial
radiological changes in High resolution computed topography.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Results publication: PubMed 33798455Behr J, Prasse A, Kreuter M, Johow J, Rabe KF, Bonella F, Bonnet R, Grohe C, Held M, Wilkens H, Hammerl P, Koschel D, Blaas S, Wirtz H, Ficker JH, Neumeister W, Schonfeld N, Claussen M, Kneidinger N, Frankenberger M, Hummler S, Kahn N, Tello S, Freise J, Welte T, Neuser P, Gunther A; RELIEF investigators. Pirfenidone in patients with progressive fibrotic interstitial lung diseases other than idiopathic pulmonary fibrosis (RELIEF): a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Respir Med. 2021 May;9(5):476-486. doi: 10.1016/S2213-2600(20)30554-3. Epub 2021 Mar 30.
- Individual participant dataSharing planned: No
Related trials for Asbestosis
Enrolling by invitationObservational study
The Edinburgh Lung Fibrosis Molecular Endotyping (ELFMEN) Study
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
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.
Marwa M Fouad, MD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Pirfenidone in people with Asbestosis, run by Cairo 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa M Fouad, MD (01004531905, marwa.fouad@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilatory function change (time frame: after 6 months and 12 months from the start of the trial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133453, which also lists 1 linked publication.
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 30 Aug 2023.