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Trial record 37 of 90 for:    asthma | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure (Gammoz)

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ClinicalTrials.gov Identifier: NCT02911688
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
To study the effects of 1200mg gamma tocopherol (yT), a form of vitamin E, given daily on the response of the airway in mild asthmatics after exposure to ozone (O3)

Condition or disease Intervention/treatment Phase
Allergic Asthma Drug: gamma tocopherol Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
Placebo Comparator: placebo
Safflower oil, taken in 2 capsules every 12 hours for a total of 4 doses
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
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




Primary Outcome Measures :
  1. change in sputum %PMNs [ Time Frame: 8 hours after final dose of study drug ]
    After supplementation with either active or placebo, subjects will undergo O3 exposure.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-45 of both genders
  2. Negative pregnancy test for females who are not s/p hysterectomy with oopherectomy
  3. History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.
  4. 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 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.
  5. FEV1 of at least 80% of predicted and FEV1/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.
  6. 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.
  7. 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.
  8. 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.
  9. for subjects who are prescribed inhaled corticosteroids. 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.

Exclusion Criteria:

  1. 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
  2. Physician directed emergency treatment for an asthma exacerbation within the preceding 3 months
  3. Moderate or Severe asthma
  4. 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.
  5. 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).
  6. Viral upper respiratory tract infection within 4 weeks of challenge.
  7. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge.
  8. Severe asthma
  9. 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.
  10. 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)
  11. Any history of smoking in the year prior to study enrollment; lifetime smoking history > 10 pack years
  12. 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
  13. Allergy/sensitivity to study drugs, or their formulations.
  14. Known hypersensitivity to methacholine or to other parasympathomimetic agents
  15. History of intubation for asthma
  16. Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
  17. Abnormal PT or aPTT values at screening or during the treatment period. Normal values will be those published by the clinical lab (Labcorp, INC).
  18. Any bleeding disorder
  19. Orthopedic conditions which would prevent the volunteer from performing moderate exercise on a treadmill.
  20. 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.


Information from the National Library of Medicine

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


Contacts
Contact: Carole A Robinette, MS 919-966-5638 carole_robinette@med.unc.edu
Contact: Martha A Almond, RCP 919-966-0759 martha_almond@med.unc.edu

Locations
United States, North Carolina
Center for Environmental Medicine, Asthma and Lung Biology Recruiting
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: David B Peden, MD UNC

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02911688     History of Changes
Other Study ID Numbers: 15-1938
4R01ES023349-04 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
gamma-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances