Cystic FibrosisNCT03256773
High Resolution Micro OCT Imaging
An observational study of Cystic Fibrosis and COPD, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, COPD, PCD - Primary Ciliary Dyskinesia
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2016to 31 Dec 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with CF, COPD, Sinusitis, PCD and COVID 19 will be enrolled.
THE INCLUSION CRITERIA:
- Patients diagnosed with CF or healthy normal controls with no respiratory disease
- Patients must be over the age of 14
- Patient must be able to give informed consent
THE EXCLUSION CRITERIA:
- Patients with recent respiratory infection requiring antibiotics or corticosteroids in the last 4 weeks (excluding routine perioperative antibiotics)
- Patients with major sinus surgery that will alter the nasal anatomy and preclude imaging of the nares
- Any condition that in the opinion of the investigator will alter the safety of pilot testing in the operating room
- Female subjects who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Imaging of Human Epithelial Airway Using a High Resolution Micro OCT Catheter (Functional Anatomic Imaging of CF Patients With Early Lung Disease Using Micro OCT)
The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.
Read the detailed description
Lung Disease is the predominate cause of morbidity and mortality in patients with cystic fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order to reveal the features that may lead to the onset of progressive lung disease. Discerning the nature of the CF defect could resolve longstanding controversy and result in a new therapeutic opportunity that may address pathophysiology. Recently the investigators have developed an innovative technology, termed 1-µm resolution optical coherence tomography (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial surface of living airways.
- Conditions
- Cystic Fibrosis, COPD, PCD - Primary Ciliary Dyskinesia, Covid19, Sinusitis, ILD
- Medical subject headings
- Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive, Ciliary Motility Disorders, COVID-19, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | No lung Disease | |
| Cystic Fibrosis | cystic fibrosis Lung Disease | |
| PCD | Primary Ciliary Dyskinesia | |
| COPD | Chronic Obstructive Lung Disease | |
| ILD | Interstitial Lung Disease | |
| COVID-19 | COVID-19 Virus | |
| Sinusitis | Sinusitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of uOCT probe
to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start15 Apr 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven M Rowe, University of Alabama at Birmingham
- Investigators
- Steven M Rowe, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256773
- Sponsor's protocol ID
- F160125001
- Other IDs
- 1R01HL116213
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2017
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Human Epithelial Airway Using a High Resolution Micro OCT Catheter (Functional Anatomic Imaging of CF Patients With Early Lung Disease Using Micro OCT)
- ClinicalTrials.gov ID
- NCT03256773
- Acronym / sponsor ID
- F160125001
- Conditions
- Cystic Fibrosis, COPD, PCD - Primary Ciliary Dyskinesia, Covid19, Sinusitis, ILD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Aug 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.
The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.
Detailed description
Lung Disease is the predominate cause of morbidity and mortality in patients with cystic fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order to reveal the features that may lead to the onset of progressive lung disease. Discerning the nature of the CF defect could resolve longstanding controversy and result in a new therapeutic opportunity that may address pathophysiology. Recently the investigators have developed an innovative technology, termed 1-µm resolution optical coherence tomography (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial surface of living airways.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –No lung Disease |
| Cystic Fibrosis | – | –cystic fibrosis Lung Disease |
| PCD | – | –Primary Ciliary Dyskinesia |
| COPD | – | –Chronic Obstructive Lung Disease |
| ILD | – | –Interstitial Lung Disease |
| COVID-19 | – | –COVID-19 Virus |
| Sinusitis | – | –Sinusitis |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with CF, COPD, Sinusitis, PCD and COVID 19 will be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
feasibility of uOCT probe
Time frame: 1 year
to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients
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 8 Jul 2026.
- 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.
Steven M Rowe principal investigator
University of Alabama at Birmingham
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 Cystic Fibrosis and COPD, run by University of Alabama at Birmingham 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?
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 8 Jul 2026. 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?
feasibility of uOCT probe (time frame: 1 year). 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 8 Jul 2026.