Respiratory Viral InfectionPhase 1MOLINCT05773001
Macrophage Regulation of Ozone-Induced Lung Inflammation
A Phase 1 study testing Ozone in people with Respiratory Viral Infection, run by Robert Tighe, MD at 1 site in United States.
Trial summary
The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Viral Infection
- What is being tested?
- Ozone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2023to May 2028
- Phase
- Phase 1
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals between 18-55 yrs. of age (No subject will be excluded from the study on the basis of gender or ethnicity)
- Individuals with knowledge of prior respiratory viral infection history allowing them to be segregated into one of three cohorts
- Cohort 1 - No history of respiratory viral infection (defined as no symptoms consistent with respiratory viral infection nor history of a positive respiratory viral test)
- Cohort 2 - Documented mild respiratory viral infection (a positive test, either PCR- or antigen-based) but with mild to no symptoms and no evidence of a lower respiratory tract infection (including no hospitalization, and no oxygen use)
- Cohort 3 - History of respiratory viral infection and symptoms/imaging consistent with a lower respiratory tract infection who have recovered, are >6 months out from their infection, and have normal lung function (spirometry with FVC, FEV1 and FEV1/FVC)
- There will be no maximal period from respiratory viral infection for inclusion in the study, the minimal period will be >6 months out from infection
Who cannot join
- Individuals with prior respiratory viral pneumonia who have ongoing respiratory symptoms, are still using supplemental oxygen, or have abnormal lung function
- Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years
- Pregnant women and women who are presently lactating.
- Subjects that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks
- College and graduate students or employees who are under direct supervision by any of the investigators in this protocol
- Alcohol or illicit substance abuse
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- Chronic cardio/pulmonary respiratory disorders or other medical conditions as determined by the investigator
- Increased airway hyperresponsiveness at baseline as measured by a positive methacholine challenge response (methacholine PC20 FEV1 < 4 mg/ml)
- Subjects will be requested to refrain from antihistamines, nonsteroidal anti-inflammatory agents, antioxidants (e.g. beta-carotene, selenium, and lutein) and supplemental vitamins (e.g. C and E), for 1 week prior to, and during testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Claudia Salazar, BS, 919-660-2026, claudia.salazar@duke.edu
Robert Tigher, MD
About this study
The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures.
Read the detailed description
Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy to evaluate the lung after the challenge.
Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series.
Total study duration is about one to one-and a half months.
- Conditions
- Respiratory Viral Infection
- Being tested
- Ozone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDrug
Also called O3
Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | no history of respiratory viral infection Receives: Drug: Ozone |
| Cohort 2 | Other | Documented mild respiratory viral infection Receives: Drug: Ozone |
| Cohort 3 | Other | Respiratory viral pneumonia Receives: Drug: Ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the abundance of monocyte-derived alveolar macrophages
Change in the abundance of monocyte-derived alveolar macrophages and association to measures of O3-induced inflammation (BAL cell neutrophils, albumin and cytokine production)
Measured: Baseline, Day 18-20
Secondary outcomes (3)
Change in the abundance of autonomous CSF-1 expression in alveolar macrophages
Change in the abundance of autonomous CSF-1 expression in alveolar macrophages and association to measures of O3-induced inflammation
Measured: Baseline, Day 18-20
Association between prior evidence of respiratory viral pneumonia
Association between prior evidence of respiratory viral pneumonia, when compared to non-infected individuals, and O3-induced inflammation
Measured: Baseline, Day 18-20
Association between prior evidence of respiratory viral infection without pneumonia
Association between prior evidence of respiratory viral infection without pneumonia, when compared to non-infected individuals and O3-induced inflammation
Measured: Baseline, Day 18-20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start18 May 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Viral InfectionStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Tighe, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor-investigator, Robert Tighe, MD, Duke University
- Investigators
- Robert Tighe, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773001
- Sponsor's protocol ID
- Pro00110603
- Other IDs
- 1R01ES034350-01
- Acronym
- MOLI
- Status last verified
- May 2026
- First submitted
- 3 Mar 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No