Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure (Gammoz)
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ClinicalTrials.gov Identifier: NCT02911688 |
Recruitment Status :
Completed
First Posted : September 22, 2016
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Allergic Asthma | Drug: gamma tocopherol Drug: Placebo | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure |
Study Start Date : | September 2016 |
Actual Primary Completion Date : | February 13, 2019 |
Actual Study Completion Date : | February 13, 2019 |

Arm | Intervention/treatment |
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Placebo Comparator: placebo
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
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Drug: Placebo
The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after placebo dosing.
Other Name: Safflower oil |
Active Comparator: gamma tocopherol
gamma tocopherol 1400 mg, taken as 2 700 mg capsules every 12 hours for a total of 4 doses
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Drug: gamma tocopherol
The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after γT dosing.
Other Name: Vitamin E |
- Change From Baseline in Sputum Percent Neutrophils (%PMN) Following Ozone Exposure [ Time Frame: baseline and 6 hours post-ozone exposure ]Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cells. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum percent neutrophils compared to placebo pre-treatment.
- Change in Sputum Percent Eosinophils From Baseline Following Ozone Exposure [ Time Frame: baseline and 6 hours post-ozone exposure ]The investigators assessed induced sputum cellularity at baseline and 6 hours after ozone exposure to determine if treatment with gamma tocopherol/placebo impacts ozone-induced sputum eosinophilia.
- Change in Sputum Interleukin (IL)-1b From Baseline Following Ozone Exposure [ Time Frame: baseline and 6 hours post ozone exposure ]Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.
- Change in Sputum IL-6 From Baseline Following Ozone Exposure [ Time Frame: baseline and 6 hours post ozone exposure ]Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.
- Change in Sputum IL-8 From Baseline Following Ozone Exposure [ Time Frame: baseline and 6 hours post ozone exposure ]Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.
- Change in Sputum Tumor Necrosis Factor (TNF)-Alpha From Baseline Following Ozone Exposure [ Time Frame: baseline and 6 hours post ozone exposure ]Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.
- Change in Sputum Mucins From Baseline Following Ozone Exposure [ Time Frame: baseline and 6 hours post ozone exposure ]Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of sputum mucins to determine if gamma tocopherol pre-treatment reduces ozone-induced sputum mucins compared to placebo pre-treatment.
- Change in Whole Lung Clearance of Technetium Sulfur Colloid Particles (0-120 Minutes) From Baseline Following Ozone Exposure [ Time Frame: baseline and 1 hour after exiting ozone chamber ]Whole lung clearance was measured using gamma scintigraphy and represented as mean average 120 minute clearance of inhaled technetium (99mTc) sulfur colloid particles in order to estimate the rate of airway mucociliary clearance.

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18-45 of both genders
- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
- History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.
- Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 15% fall in forced expiratory volume in 1 second (FEV1) (PC20 methacholine) by the method used in a separate screening protocol or a pre and post bronchodilator challenge used to determine reversible lung function. Reversibility is confirmed with a 10-12% increase in FEV1 15 minutes after inhaling 4 puffs of albuterol with a spacer. Reversibility is used in the same separate screening protocol; or a clinical history of asthma after the age of 6.
- FEV1 of at least 80% of predicted and FEV1/Forced Vital Capacity (FVC) ratio of at least .70 (without use of bronchodilating medications for 12 hours or long acting beta agonists for 24 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma.
- Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response; or a clinical history consistent with seasonal or perennial allergy symptoms.
- Symptom Score (this will be submitted as an attachment) no greater than 20 (out of a possible 60) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3.
- subjects must be willing to avoid caffeine for 12 hours prior to all visits. Methacholine challenge and allergy skin testing are performed as part of IRB 98-0799, which a subject must complete in order to be considered for this protocol.
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for subjects who are prescribed inhaled corticosteroids (ICS). These volunteers must be able to come off of the ICS for 2 weeks without increased symptoms or increased need for beta agonist rescue medication prior to screening and throughout the course of the study.
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Exclusion Criteria:
- Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis
- Physician directed emergency treatment for an asthma exacerbation within the preceding 3 months
- Moderate or Severe asthma
- Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
- Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).
- Viral upper respiratory tract infection within 4 weeks of challenge.
- Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge.
- Severe asthma
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Medications which may impact the results of the O3 exposure, interfere with any other medications potentially used in the study (to include systemic steroids, beta antagonists, non-steroidal anti-inflammatory agents)
- Any history of smoking in the year prior to study enrollment; lifetime smoking history > 10 pack years
- Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma
- Allergy/sensitivity to study drugs, or their formulations.
- Known hypersensitivity to methacholine or to other parasympathomimetic agents
- History of intubation for asthma
- Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
- Abnormal Prothrombin Time (PT) or activated Partial Thromboplastin Time (aPTT) values at screening or during the treatment period. Normal values will be those published by the clinical lab (Labcorp, INC).
- Any bleeding disorder
- Orthopedic conditions which would prevent the volunteer from performing moderate exercise on a treadmill.
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Radiation exposure history will be collected. Subjects whose exposure history within the past twelve months would cause them to exceed their annual limits will be excluded.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911688
United States, North Carolina | |
Center for Environmental Medicine, Asthma and Lung Biology | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | David B Peden, MD | UNC |
Documents provided by University of North Carolina, Chapel Hill:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT02911688 |
Other Study ID Numbers: |
15-1938 4R01ES023349-04 ( U.S. NIH Grant/Contract ) |
First Posted: | September 22, 2016 Key Record Dates |
Results First Posted: | January 18, 2020 |
Last Update Posted: | January 18, 2020 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Vitamin E Tocopherols Tocotrienols alpha-Tocopherol gamma-Tocopherol Vitamins Micronutrients |
Nutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |