Idiopathic Pulmonary FibrosisNCT03171870
Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis
A study testing high resolution computed tomography in people with Idiopathic Pulmonary Fibrosis, run by Assiut University.
Trial summary
Idiopathic pulmonary fibrosis is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, limited to the lungs, and associated with the histopathologic and/or radiologic pattern of usual interstitial pneumonia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- high resolution computed tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic Pulmonary fibrosis will be diagnosed by presence of UIP pattern. Other forms of ILD will be diagnosed using HRCT by presence of Reticular abnormality Honeycombing with or without traction Extensive ground glass abnormality.
- Profuse micronodules.
Who cannot join
- Patients who refused to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical, Radiological Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis Patients
Idiopathic pulmonary fibrosis is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, limited to the lungs, and associated with the histopathologic and/or radiologic pattern of usual interstitial pneumonia.
The definition of Idiopathic pulmonary fibrosis requires the exclusion of other forms of interstitial pneumonia including other idiopathic interstitial pneumonias and Interstitial lung disease associated with environmental exposure, medication, or systemic disease.
Prevalence estimates for Idiopathic pulmonary fibrosis have varied from 2 to 29 cases per 100,000 in the general population IPF should be considered in all adult patients with unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar inspiratory crackles, and finger clubbing.
Read the detailed description
Idiopathic pulmonary fibrosis should be considered in all adult patients with unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar inspiratory crackles, and finger clubbing.
High resolution chest computed tomography is an essential component of the diagnostic pathway in Idiopathic pulmonary fibrosis. usual interstitial pneumonia is characterized on high resolution chest computed tomography by the presence of reticular opacities, often associated with traction bronchiectasis.
Patients with interstitial lung disease have poor health-related quality of life. However, whether health-related quality of life differs among different subtypes of interstitial lung disease is unclear.
There is limited research on the health-related quality of life of Idiopathic pulmonary fibrosis patients.
Health-related quality of life deficits should be monitored in clinical practice with Idiopathic pulmonary fibrosis patients and considered when investigating new therapies
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- high resolution computed tomography
- 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.
high resolution computed tomographyDiagnostic test
high resolution computed tomography is an essential component of the diagnostic pathway in idiopathic pulmonary fibrosis. Unusual interstitial pneumonia is characterized on high resolution computed tomography by the presence of reticular opacities, often associated with traction bronchiectasis
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Pulmonary Fibrosis | Other | Idiopathic pulmonary fibrosis patients on high resolution computed tomography characterized by presence of reticular opacities often associated with traction bronchiectasis Receives: Diagnostic Test: high resolution computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare Health Related Quality of Life in Idiopathic pulmonary fibrosis patients with other forms of interstitial lung disease
St.george respiratory questionnaire
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Souad sameh sayed, Assiut University
- Investigators
- Maha Ghanen, Study chair, Assiut UniversityHoda Makhlouf, Study chair, Assiut UniversityAli Hasan, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171870
- Sponsor's protocol ID
- IPF
- Status last verified
- May 2017
- First submitted
- 26 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han MK, McLaughlin VV, Criner GJ, Martinez FJ. Pulmonary diseases and the heart. Circulation. 2007 Dec 18;116(25):2992-3005. doi: 10.1161/CIRCULATIONAHA.106.685206.
PubMed 18086941
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiological Characteristics and Health Related Quality of Life in Idiopathic Pulmonary Fibrosis Patients
- ClinicalTrials.gov ID
- NCT03171870
- Acronym / sponsor ID
- IPF
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 31 May 2017 (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 is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, limited to the lungs, and associated with the histopathologic and/or radiologic pattern of usual interstitial pneumonia.
The definition of Idiopathic pulmonary fibrosis requires the exclusion of other forms of interstitial pneumonia including other idiopathic interstitial pneumonias and Interstitial lung disease associated with environmental exposure, medication, or systemic disease.
Prevalence estimates for Idiopathic pulmonary fibrosis have varied from 2 to 29 cases per 100,000 in the general population IPF should be considered in all adult patients with unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar inspiratory crackles, and finger clubbing.
Detailed description
Idiopathic pulmonary fibrosis should be considered in all adult patients with unexplained chronic exertional dyspnea, and commonly presents with cough, bibasilar inspiratory crackles, and finger clubbing.
High resolution chest computed tomography is an essential component of the diagnostic pathway in Idiopathic pulmonary fibrosis. usual interstitial pneumonia is characterized on high resolution chest computed tomography by the presence of reticular opacities, often associated with traction bronchiectasis.
Patients with interstitial lung disease have poor health-related quality of life. However, whether health-related quality of life differs among different subtypes of interstitial lung disease is unclear.
There is limited research on the health-related quality of life of Idiopathic pulmonary fibrosis patients.
Health-related quality of life deficits should be monitored in clinical practice with Idiopathic pulmonary fibrosis patients and considered when investigating new therapies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Pulmonary Fibrosis | Other | Diagnostic Test: high resolution computed tomographyIdiopathic pulmonary fibrosis patients on high resolution computed tomography characterized by presence of reticular opacities often associated with traction bronchiectasis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic Pulmonary fibrosis will be diagnosed by presence of UIP pattern. Other forms of ILD will be diagnosed using HRCT by presence of Reticular abnormality Honeycombing with or without traction Extensive ground glass abnormality.
- Profuse micronodules.
Key exclusion criteria (1 listed)
- Patients who refused to participate in the study.
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 |
|---|---|---|
| high resolution computed tomographyhigh resolution computed tomography is an essential component of the diagnostic pathway in idiopathic pulmonary fibrosis. Unusual interstitial pneumonia is characterized on high resolution computed tomography by the presence of reticular opacities, often associated with traction bronchiectasis | Diagnostic test | Idiopathic Pulmonary Fibrosis |
Primary outcome
To compare Health Related Quality of Life in Idiopathic pulmonary fibrosis patients with other forms of interstitial lung disease
Time frame: 10 minutes
St.george respiratory questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 18086941Han MK, McLaughlin VV, Criner GJ, Martinez FJ. Pulmonary diseases and the heart. Circulation. 2007 Dec 18;116(25):2992-3005. doi: 10.1161/CIRCULATIONAHA.106.685206.
- Individual participant dataSharing planned: No
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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.
Maha Ghanen study chair
Assiut University
Hoda Makhlouf study chair
Assiut University
Ali Hasan study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing high resolution computed tomography in people with 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 2 inclusion and 1 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 31 May 2017. 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 Souad Sameh (01025945691, Sss.elsrogy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare Health Related Quality of Life in Idiopathic pulmonary fibrosis patients with other forms of interstitial lung disease (time frame: 10 minutes). 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 NCT03171870, 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 31 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.