A Phase 2 interventional study of Gamma Tocopherol and Placebo in Airway Inflammation and Asthma, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Treatment
Among 30 studies in Asthma by University of North Carolina, Chapel Hill — 1 open to participants now, 1 under way, none of them phase 3. Asthma · University of North Carolina, Chapel Hill.
Among the 30 studies in Asthma by University of North Carolina, Chapel Hill, this one is the 12th largest by enrollment of the 25 interventional ones that give a count, is one of 3 that started in 2018, is one of 3 in phase 2, and was the 21st registered.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
Browse Asthma studies →1 of the 30 studies in Asthma by University of North Carolina, Chapel Hill is open now, in 1 country. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 6
First in 1999; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Median enrollment 16 across the 25 interventional studies, 39 across the 4 observational. Of the 23 that completed or were terminated, 9 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 30 studies in Asthma by University of North Carolina, Chapel Hill, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Purpose: To determine the efficacy of 1400 mg gamma tocopherol-enriched supplement for mitigating inhaled wood smoke particle-induced airway inflammation in healthy adults with no more than mild asthma.
Particulate matter (PM) is a leading cause of respiratory tract and cardiovascular disease in the United States and world-wide. Wood smoke particles (WSP) derived from wildland and other fires account for a significant fraction of ambient air PM. Health effects associated with WSP include acute bronchitis, asthma exacerbation, pneumonia, cough and systemic inflammation. While these effects are seen in both healthy and asthmatic individuals, many studies indicate that asthmatics have increased susceptibility to the effects of WSP. The investigators have developed a 500 μg/m3 WSP exposure protocol (levels similar to those encountered by firefighters and residents in close proximity to wildland burn sites) that induces airway and systemic inflammation in healthy volunteers. As with other pollutants, these inflammatory responses modulate non-specific bronchial reactivity (NSBR), inflammatory cell recruitment to the airways (primarily neutrophils), and potentially cardiovascular function.
The investigators have focused on gamma tocopherol (γT) as a nutritional intervention to prevent inflammatory responses to air pollutants such as WSP. Building on animal and in vitro preclinical studies, the investigators have established that 1400 mg/day of oral γT-enriched supplement for 7 and 14 days in healthy volunteers and mild asthmatics, respectively, inhibited neutrophil influx into the airways, reduced production of sputum mucins, and improved mucociliary clearance following challenge with inhaled endotoxin, another common component of PM. The findings occurred in the context of significantly increased plasma concentrations of γT and its active metabolite 2,7,8-trimethyl-2-(β-Carboxy-Ethyl)-6-Hydroxychroman (γ-CEHC). Given the findings in these early phase clinical trials, γT supplementation is an attractive approach to prevent WSP-induced adverse health effects. The investigators propose to use γT supplementation in a human model of WSP inhalation to mitigate key features of airway inflammation: inflammatory cell recruitment, production of inflammatory cytokines and mucous, and changes in airway physiology.
Gamma tocopherol will be administered in softgel form, with each softgel containing 700 mg of tocopherols, 89.5% of which is d-gamma tocopherol. Subjects will consume two softgels by mouth once daily for 7 days. This dosing regimen was chosen based on the results of the investigators' previous early phase clinical trials examining the impact of gamma tocopherol on lipopolysaccharide (LPS) -induced airway inflammation in healthy adults and adults with asthma. These studies tested a 7 and 14 day course of treatment, respectively, and found similar plasma concentrations of γT and active metabolites in both studies. Furthermore, the investigators showed in both studies that γT significantly reduced LPS-induced sputum neutrophilia compared to placebo. Based on the previous findings, the investigators will now study the efficacy of γT for mitigating WSP-induced airway inflammation.
January 2022 update: The existing, custom source of gamma tocopherol expired during the protocol paused period during Covid. The Gamma t is replaced by Gamma E Gems, manufactured by Carlson Labs, each capsule with 577mg of gamma tocopherol, based on Certificate of Analysis. Subjects will continue to ingest 2 capsules at each dosing, for a total dose of 1154mg. The safflower oil placebo is replaced with a neutral oil capsule.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Patients who meet any of these criteria are not eligible for enrollment as study participants:
Clinical :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants that are randomized to placebo treatment will take a short treatment course of Neutral Oil followed by chamber exposure with wood smoke particulate. After a 4-week washout period, participants will cross over to the gamma Tocopherol (active) treatment group.
Drug: Gamma Tocopherol · Drug: Placebo
Participants that are randomized γT treatment will take a short treatment course of gamma Tocopherol followed by chamber exposure with WSP. After a 4-week washout period, participants will cross over to the placebo treatment group.
Drug: Gamma Tocopherol · Drug: Placebo
Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.
Also known as: Vitamin E
Each dose consists of two capsules by mouth once daily for a total of 7 days.
Also known as: Neutral oil
Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure
A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.
Time frame: baseline, and 4 hours post exposure
Change in Sputum % PMNs With WSP Exposure
A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.
Time frame: baseline, and 24 hours post exposure
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure
A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.
Time frame: baseline, and 4 hours post exposure
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure
A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.
Time frame: baseline, and 24 hours post exposure
| Milestone | Placebo First, Then Gamma Tocopherol | GammaTocopherol First, Then Placebo |
|---|---|---|
| Started | 7 | 9 |
| Completed | 7 | 9 |
| Not completed | 0 | 0 |
| Milestone | Placebo First, Then Gamma Tocopherol | GammaTocopherol First, Then Placebo |
|---|---|---|
| Started | 7 | 9 |
| Completed | 4 | 7 |
| Not completed | 3 | 2 |
| Milestone | Placebo First, Then Gamma Tocopherol | GammaTocopherol First, Then Placebo |
|---|---|---|
| Started | 4 | 7 |
| Completed | 4 | 7 |
| Not completed | 0 | 0 |
A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.
| percent PMNs | GammaTocopherol | Placebo |
|---|---|---|
| Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure | 18.00 ± 20.89 | 14.75 ± 17.98 |
A comparison of the WSP-induced change in sputum % PMNs (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum % PMNs during placebo treatment.
| percent PMNs | GammaTocopherol | Placebo |
|---|---|---|
| Change in Sputum % PMNs With WSP Exposure | 39.87 ± 20.59 | 29.35 ± 28.30 |
A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.
| PMNs per mg sputum | GammaTocopherol | Placebo |
|---|---|---|
| Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure | 8.58 ± 150.6 | -20.51 ± 160.6 |
A comparison of the WSP-induced change in sputum ANC (Post-WSP sputum - Pre-WSP sputum) during gamma tocopherol treatment with the WSP-induced change in sputum ANC during placebo treatment.
| PMNs per mg sputum | GammaTocopherol | Placebo |
|---|---|---|
| Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure | 104.7 ± 146.5 | 96.7 ± 156.2 |
A comparison of the WSP-induced sputum % eosinophils versus predosing values with gamma tocopherol and placebo treatment.
| percent eosinophils | Pre-Dosing | GammaTocopherol | Placebo |
|---|---|---|---|
| 4 Hours | 0.07 ± 0.04 | 0.04 ± 0.08 | 2.3 ± 1.6 |
| 24 Hours | 0.07 ± 0.04 | 0.26 ± 0.15 | 0.39 ± 0.33 |
A comparison of the WSP-induced sputum eosinophils after gamma tocopherol and placebo pre dosing values.
| Cells per mg (eosinophils) | Pre-Dosing | GammaTocopherol | Placebo |
|---|---|---|---|
| 4 Hours | 0.17 ± 0.33 | 0.20 ± 0.52 | 7.10 ± 12.33 |
| 24 Hours | 0.17 ± 0.33 | 1.15 ± 2.11 | 1.02 ± 2.70 |
The IL-1β concentration will be determined in each sputum sample by immunoassay
| pg/mL | Pre-Dosing | GammaTocopherol | Placebo |
|---|---|---|---|
| 4 Hours | 798.3 ± 497.1 | 674.2 ± 494.9 | 654.4 ± 438.3 |
| 24 Hours | 798.3 ± 497.1 | 469.6 ± 237.4 | 675.2 ± 630.6 |
The IL-6 concentration will be determined in each sputum sample by immunoassay
| pg/mL | Pre-Dosing | GammaTocopherol | Placebo |
|---|---|---|---|
| 4 Hours | 458.0 ± 492.3 | 384.8 ± 440.2 | 277.5 ± 255.5 |
| 24 Hours | 458.0 ± 492.3 | 207.0 ± 171.6 | 281.3 ± 338.0 |
The IL-8 concentration will be determined in each sputum sample by immunoassay
| pg/mL | Pre-Dosing | GammaTocopherol | Placebo |
|---|---|---|---|
| 4 Hours | 30850 ± 28306 | 31724 ± 37505 | 25432 ± 23198 |
| 24 Hours | 30850 ± 28306 | 17180 ± 13083 | 36739 ± 60134 |
The TNF-a concentration will be determined in each sputum sample by immunoassay
| pg/mL | Pre-Dosing | GammaTocopherol | Placebo |
|---|---|---|---|
| 4 Hours | 35.67 ± 25.88 | 127.7 ± 342.7 | 25.18 ± 20.84 |
| 24 Hours | 35.67 ± 25.88 | 13.77 ± 12.63 | 29.23 ± 26.18 |
The alpha tocopherol concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).
| microM | GammaTocopherol | Placebo |
|---|---|---|
| Alpha Tocopherol in Blood | 22.54 ± 10.17 | 24.58 ± 3.40 |
The 2, 7,8-trimethyl-2S-(g-carboxyethyl)-6-hydroxychromane (g-CEHC) concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).
| microM | GammaTocopherol | Placebo |
|---|---|---|
| 2, 7,8-trimethyl-2S-(G-carboxyethyl)-6-hydroxychromane (g-CEHC) in Blood | 1.912 ± 2.021 | 0.084 ± 0.08 |
The gamma tocopherol concentration will be determined in blood samples by high-performance liquid chromatography (HPLC).
| microM | GammaTocopherol | Placebo |
|---|---|---|
| GammaTocopherol in Blood | 32.60 ± 7.45 | 4.64 ± 1.71 |
Collected over From the time a participant signed consent through completion of the second intervention, a total of up to 5 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GammaTocopherol | 0/13 (0%) | 0/13 (0%) | 8/13 (61.5%) |
| Placebo | 0/14 (0%) | 0/14 (0%) | 7/14 (50%) |
| Event | GammaTocopherol | Placebo |
|---|---|---|
| Gastrointestinal DistressGastrointestinal disorders | 7/13 | 2/14 |
| HeadacheGeneral disorders | 2/13 | 3/14 |
| Viral Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 1/13 | 1/14 |
| Eye IrritationEye disorders | 1/13 | 0/14 |
| NosebleedVascular disorders | 1/13 | 0/14 |
| Unusual Fatigue or TirednessGeneral disorders | 1/13 | 1/14 |
| Premature Ventricular ContractionCardiac disorders | 1/13 | 0/14 |
| Menstrual CrampsGeneral disorders | 1/13 | 0/14 |
| SweatingSkin and subcutaneous tissue disorders | 1/13 | 1/14 |
| Throat IrritationRespiratory, thoracic and mediastinal disorders | 1/13 | 0/14 |
| Age, Categorical(Participants) | Placebo First, Then Gamma Tocopherol | GammaTocopherol First, Then Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 9 | 16 |
| >=65 years | 00 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo First, Then Gamma Tocopherol | GammaTocopherol First, Then Placebo | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 1 | 4 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Placebo First, Then Gamma Tocopherol | GammaTocopherol First, Then Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 5 | 7 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo First, Then Gamma Tocopherol | GammaTocopherol First, Then Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 3 | 8 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo First, Then Gamma Tocopherol | GammaTocopherol First, Then Placebo | Total |
|---|---|---|---|
| United States | 7 | 9 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Mar 2023, 56 months.
Results were first posted in Feb 2024, 11 months after primary completion.
Of 61 non-industry phase 2 interventional studies under Asthma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 62. This study's 56 months is above that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Gamma-Tocopherol
University of North Carolina, Chapel Hill →