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

Completed · Phase 2 · Has a placebo group

Conditions studied: Allergic Asthma

In brief

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

Key facts

Study ID

NCT02911688

Run by

University of North Carolina, Chapel Hill

People needed

18

Starts

2016-09-01

Expected to finish

2019-02-13

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Center for Environmental Medicine, Asthma and Lung Biology — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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