CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
gamma tocopherol +1 moredrug
Likely dose
Gamma tocopherol supplementation dose not specified; placebo controlAI-extracted
Key inclusion· 5
  • ✓Age 18-45, both genders
  • ✓History of asthma confirmed by either methacholine challenge (PC20 ≤10 mg/ml) with reversibility, or clinical diagnosis
  • ✓FEV1 ≥80% predicted and FEV1/FVC ratio ≥0.70, consistent with mild episodic or mild persistent asthma
  • ✓Allergic sensitization to at least one common allergen (dust mite, cockroach, tree/grass/weed mix, mold, pet, rodent) confirmed by positive skin test or clinical allergy history
Key exclusion· 10
  • ✕Moderate or severe asthma
  • ✕Asthma exacerbation ≥2 times per week or daily albuterol requirement (excluding prophylactic pre-exercise use)
  • ✕Emergency treatment for asthma exacerbation within 3 months prior to enrollment
  • ✕Nighttime cough or wheeze >1 time per week at baseline

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02911688
NCT02911688Phase 2Completed
CompareCT.gov

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

University of North Carolina, Chapel Hill·interventional·Posted Sep 22, 2016·Updated Jan 18, 2020

In Brief

A Phase 2 clinical trial evaluating gamma tocopherol and Placebo for Allergic Asthma. Completed, enrolled 18 participants across 1 site.

Detailed Summary

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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Asthma
CountriesUnited States
CollaboratorsNational Institute of Environmental Health Sciences (NIEHS)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 22, 2016
Enrollment StartSep 1, 2016
Primary CompletionFeb 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.8 years ago

Interventions

gamma tocopheroldrug

The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after γT dosing.

Placebodrug

The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after placebo dosing.