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Phase 2 Completed N=16 Randomized Triple-blind Treatment

A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults

Airway Inflammation · Asthma
Source: ClinicalTrials.gov NCT03444298 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure — 18.00; 14.75 percent PMNs — p=0.67

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure
18.00; 14.75 0.67
PRIMARY
Change in Sputum % PMNs With WSP Exposure
39.87; 29.35 0.43
SECONDARY
Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure
104.7; 96.7 0.92

Eligibility Criteria

Inclusion Criteria

  • Age 18-45 years, inclusive, of both genders
  • Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
  • Forced expiratory volume at one second (FEV1) of at least 75% of predicted (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild intermittent or mild persistent asthma.
  • Oxygen saturation of 150mm Hg or 90 mm Hg or 1 pack per month
  • 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).
  • Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS. Oral contraceptives are acceptable, as are Antidepressants and other medications may be permitted if, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise safety and if the dosage has been stable for 1 month.
  • Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.
  • Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
  • Allergy/sensitivity to study drugs or their formulations
  • Known hypersensitivity to methacholine or to other parasympathomimetic agents
  • Unwillingness to avoid coffee, tea, cola drinks, chocolate, or other foods containing caffeine after midnight on the days that methacholine challenge testing is to be performed.
  • Pregnant/nursing women and children (< 18 years as this is age of majority in North Carolina) will also be excluded since the risks associated with woodsmoke exposure to the fetus or child, respectively, are unknown and cannot be justified for this non-therapeutic protocol. Individuals over 45 years of age will not be included due to the increased possibility of co-morbidities and need for prohibited medications.
  • Inability or unwillingness of a participant to give written informed consent.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03444298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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