IPFAPPLeNCT04564183
Advancing Prevention of Pulmonary Fibrosis
An observational study of IPF and Pulmonary Fibrosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about pulmonary fibrosis and how it develops. We want to determine if the disease can be detected early, before the lung is permanently scarred. This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- IPF, Pulmonary Fibrosis, ILD
- What is being tested?
- Sample collection, Questionnaires and High resolution CT scan of the chest
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 1 Aug 2026
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will enroll up to 1,000 participants who are in families with two or more reported cases of pulmonary fibrosis.
Who may be able to join
- Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP)
- Age at least 40 years old and younger than 75 years old
Who cannot join
- Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent
- Other genetic diseases associated with interstitial lung disease
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis
This study plans to learn more about pulmonary fibrosis and how it develops. We want to determine if the disease can be detected early, before the lung is permanently scarred.
This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary fibrosis. Because there is an increased risk within affected families, this cohort will allow us to learn how pulmonary fibrosis develops, and how the lungs change over time.
- Conditions
- IPF, Pulmonary Fibrosis, ILD
- Being tested
- Sample collection, Questionnaires, High resolution CT scan of the chest, Pulmonary Function Test
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Blood, Urine, Nail, Hair, Saliva, optional Stool
QuestionnairesOther
SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire
High resolution CT scan of the chestRadiation
Upon enrollment, all participants will undergo single prone volumetric thoracic chest CT scan. This will be performed at full inspiration using a 64-slice CT scanner.
Pulmonary Function TestDiagnostic test
All recruited participants will undergo a pre-bronchodilator spirometry test and a lung diffusion capacity test, both in accordance with ATS guidelines. Exercise capacity (maximum physical exertion) will be assessed by performing a 6-minute walk test, also according to ATS guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Full Cohort | Entire study population Receives: Other: Sample collection; Other: Questionnaires; Radiation: High resolution CT scan of the chest; Diagnostic Test: Pulmonary Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest
All subjects will be screened with a high resolution CT scan to identify early signs of lung fibrosis. CT scans will be evaluated by study radiologists.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start22 Jan 2021
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of California, Los Angeles, University of Texas, University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- David Schwartz, MD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564183
- Sponsor's protocol ID
- 20-1739
- Acronym
- APPLe
- Status last verified
- Mar 2025
- First submitted
- 18 Sep 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04564183
- Acronym / sponsor ID
- APPLe / 20-1739
- Conditions
- IPF, Pulmonary Fibrosis, ILD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of California, Los Angeles, University of Texas, University of Pennsylvania
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Sep 2020 (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 plans to learn more about pulmonary fibrosis and how it develops. We want to determine if the disease can be detected early, before the lung is permanently scarred.
This study will enroll participants who are not currently diagnosed with pulmonary fibrosis, but who have family members with pulmonary fibrosis. Because there is an increased risk within affected families, this cohort will allow us to learn how pulmonary fibrosis develops, and how the lungs change over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Cohort | – | Other: Sample collection, Other: Questionnaires, Radiation: High resolution CT scan of the chest, Diagnostic Test: Pulmonary Function TestEntire study population |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll up to 1,000 participants who are in families with two or more reported cases of pulmonary fibrosis.
Key inclusion criteria (2 listed)
- Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP)
- Age at least 40 years old and younger than 75 years old
Key exclusion criteria (3 listed)
- Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent
- Other genetic diseases associated with interstitial lung disease
- Pregnant women
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 |
|---|---|---|
| Sample collectionBlood, Urine, Nail, Hair, Saliva, optional Stool | Other | Full Cohort |
| QuestionnairesSF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire | Other | Full Cohort |
| High resolution CT scan of the chestUpon enrollment, all participants will undergo single prone volumetric thoracic chest CT scan. This will be performed at full inspiration using a 64-slice CT scanner. | Radiation | Full Cohort |
| Pulmonary Function TestAll recruited participants will undergo a pre-bronchodilator spirometry test and a lung diffusion capacity test, both in accordance with ATS guidelines. Exercise capacity (maximum physical exertion) will be assessed by performing a 6-minute walk test, also according to ATS guidelines. | Diagnostic test | Full Cohort |
Primary outcome
Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest
Time frame: Baseline
All subjects will be screened with a high resolution CT scan to identify early signs of lung fibrosis. CT scans will be evaluated by study radiologists.
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 25 Mar 2025.
- Individual participant dataSharing planned: No
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A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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Role of Genetic Factors in the Development of Lung Disease
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Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
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RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
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.
David Schwartz, MD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IPF and Pulmonary Fibrosis, run by University of Colorado, Denver at 1 site in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Screen all subjects for early Idiopathic Pulmonary Fibrosis (IPF) with High Resolution CT Scan of the Chest (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 25 Mar 2025.