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Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled LPS (Vitalps)

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ClinicalTrials.gov Identifier: NCT02104505
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
National Institute of Environmental Health Sciences (NIEHS)
Purdue University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
To test the hypothesis that gamma tocopherol (vitamin E) supplement inhibits endotoxin induced airways inflammation in allergic asthmatics

Condition or disease Intervention/treatment Phase
Mild, Allergic Asthma Drug: Gamma Tocopherol 700 mg capsules, Drug: Placebo Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 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 LPS
Actual Study Start Date : November 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : August 2017


Arm Intervention/treatment
Active Comparator: 700 mg Gamma Tocopherol daily x 14days
Gamma Tocopherol supplement
Drug: Gamma Tocopherol 700 mg capsules,
2 capsules daily

Placebo Comparator: Placebo
Safflower oil capsules
Drug: Placebo
Safflower oil capsules




Primary Outcome Measures :
  1. Comparison of Change in Sputum Percent Neutrophils (PMN)s Following Inhaled Clinical Center Reference Endotoxin (CCRE) Challenge as Affected by Gamma Tocopherol [ Time Frame: after 14 days of gamma tocopherol or placebo treatment ]
    In asthmatic individuals, exposure to CCRE is expected to increase PMNs in the sputum. The sputum PMNs were measured at baseline (immediately prior to dosing) and again on day 14 of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare the change in PMNs from baseline to post treatment after exposure to CCRE


Secondary Outcome Measures :
  1. Chronic Eosinophilic Airway Inflammation as Affected by Gamma Tocopherol [ Time Frame: after 14 days of gamma tocopherol or placebo treatment ]
    The sputum eosinophils were measured at baseline (immediately prior to dosing) and again after 14 days of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare sputum eosinophils per mg before and after gamma tocopherol treatment.

  2. Mucociliary Clearance (MCC) Associated With CCRE Challenge as Affected by Gamma Tocopherol [ Time Frame: after 14 days of gamma tocopherol or placebo treatment ]
    On day 14 of treatment (approximately 6 hours after the final dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period.

  3. Mucociliary Clearance as Affected by Gamma Tocopherol [ Time Frame: after 11 days of gamma tocopherol or placebo treatment ]
    On day 11 of treatment (approximately 6 hours after the daily dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-50 of both genders
  2. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
  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 20% fall in Forced Expiratory Volume in 1 second (FEV1) (PC20 methacholine) by the method used in a separate screening protocol.
  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.
  7. Symptom Score (this will be submitted as an attachment) no greater than 16 (out of a possible 24) 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.

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 12 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 National Heart, Lung and Blood Institute (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 2 weeks of challenge.
  7. Any acute infection requiring antibiotics within 2 weeks of exposure or fever of unknown origin within 2 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 Clinical Center Reference Endotoxin (CCRE) exposure, interfere with any other medications potentially used in the study (to include 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, including E coli, 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 (Intrauterine device, birth control pills/patch, condoms).
  17. Abnormal Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) 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. 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.
  20. Pregnancy

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): NCT02104505


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02104505     History of Changes
Other Study ID Numbers: 13-1605
R01ES023349 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2014    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
gamma-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances