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Vitamin Supplement

Placebo for Bronchitis (SmokeyT Trial)

Phase 2

Waitlist Available

Led By David Peden, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and 24 hours post exposure

Awards & highlights

SmokeyT Trial Summary

This trial will test whether a 1400 mg gamma tocopherol-enriched supplement can help mitigate airway inflammation in healthy adults with mild asthma, caused by inhaling wood smoke particles.

Eligible Conditions

Bronchitis
Asthma

SmokeyT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and 24 hours post exposure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, and 24 hours post exposure

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and 24 hours post exposure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Sputum % PMNs With WSP Exposure

Change in Sputum % Polymorphonuclear Neutrophils (PMN) With Wood Smoke Particulate (WSP) Exposure

Secondary outcome measures

Change in Absolute PMN Count (ANC) in Sputum With WSP Exposure

SmokeyT Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: GammaTocopherol first, then PlaceboActive Control2 Interventions

Participants that are randomized γT treatment will take a short treatment course of gamma Tocopherol followed by chamber exposure with WSP. After a 4-week washout period, participants will cross over to the placebo treatment group.

Group II: Placebo first, then Gamma TocopherolPlacebo Group2 Interventions

Participants that are randomized to placebo treatment will take a short treatment course of Neutral Oil followed by chamber exposure with wood smoke particulate. After a 4-week washout period, participants will cross over to the gamma Tocopherol (active) treatment group.

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,506 Previous Clinical Trials

4,190,545 Total Patients Enrolled

4 Trials studying Bronchitis

3,106 Patients Enrolled for Bronchitis

National Institute of Environmental Health Sciences (NIEHS)NIH

284 Previous Clinical Trials

1,232,721 Total Patients Enrolled

3 Trials studying Bronchitis

63,267 Patients Enrolled for Bronchitis

David Peden, MDPrincipal InvestigatorUNC

3 Previous Clinical Trials

29 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment offering participation to individuals aged 50 and above?

"Participants aged 18 years and older but younger than 45 are eligible for enrolment in this medical trial."

Answered by AI

Is there a particular demographic that can partake in this research project?

"To qualify for this medical trial, potential participants must have been diagnosed with asthma and be within the parameters of 18 to 45 years old. The team is seeking up to 35 individuals in total."

Answered by AI

Are there any recorded precedents of this treatment being tested in a medical trial?

"Currently, 12 trials are running related to this drug treatment. Three of them have progressed to the third phase of testing. The majority are based in Salt Lake City, Utah; however, 30 different clinical sites across the country are participating in these studies."

Answered by AI

To what ailments is this remedy commonly recommended?

"This treatment regime is suitable for treating long-chain omega-3 fatty acid deficiencies, vitamin depletions and may also include dietary supplementation."

Answered by AI

How many individuals have enrolled in the research project thus far?

"Affirmative. The clinicaltrials.gov database shows that this medical trial, which was created on June 8th 2018, is still accepting participants. In total, 35 individuals need to be recruited from a single location for the study's completion."

Answered by AI

Are there vacancies available for participation in this clinical trial?

"As per information available on clinicaltrials.gov, this experiment is actively looking to enrol patients; it was first posted in June 8th 2018 and was last edited March 17th 2022."

Answered by AI

To what extent could this treatment pose a hazard to individuals?

"As this is a Phase 2 trial, meaning that there is some evidence of safety but no data concerning efficacy, we at Power have given it an overall rating of 2."

Answered by AI