empty (-cigarette sham control) for Inflammation

Phase-Based Estimates
1
Effectiveness
1
Safety
UCLA, Los Angeles, CA
Inflammation+1 More
empty (-cigarette sham control) - Other
Eligibility
18 - 65
All Sexes
Eligible conditions
Inflammation

Study Summary

This study is evaluating whether electronic cigarettes have the potential to cause oxidative stress and inflammation.

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Eligible Conditions

  • Inflammation
  • E-cigarettes, Oxidative Stress, Inflammation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether empty (-cigarette sham control) will improve 1 primary outcome and 1 secondary outcome in patients with Inflammation. Measurement will happen over the course of within 4 hours of e-cig use.

Hour 4
Cellular Reactive Oxygen Species, units = % fluorescence
Hour 4
CD 14+ Monocyte, units = % of total cells

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
E-cig

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Empty (-cigarette Sham Control) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

E-cig
Other
One time exposure to e-cig
sham
Other
One time exposure to empty e-cig

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 4 hours of e-cig use
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 4 hours of e-cig use for reporting.

Who is running the study

Principal Investigator
H. R. M.
Holly R Middlekauff, Principal Investigator
University of California, Los Angeles

Closest Location

UCLA - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Healthy

Patient Q&A Section

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

What causes inflammation?

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The mechanism causing inflammation may be the common denominator for a number of important autoimmune diseases including diabetes. Thus if we understand inflammation and the molecular components that stimulate and maintain it we may be closer to new ways to treat a wide range of autoimmune disease.

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Can inflammation be cured?

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Inflammation cannot be cured, but can be adequately controlled in patients at highest risk. More effective treatments and improved diagnostics are needed to manage symptoms.

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What are the signs of inflammation?

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Inflammation can be caused by infections, autoimmune diseases, malignancies, inflammatory bowel disease, anemia or other inflammatory syndromes, or external stimuli. Signs of chronic inflammation may include abdominal bloating, fatigue, malaise, weight loss, diarrhea, constipation or indigestion, or joint pain. There are signs of other inflammations such as thyroid disease. Inflammatory and autoimmune diseases can also affect the lungs and skin. Signs of infection can include fever, malaise, night sweats or swollen lymph nodes. This may accompany many autoimmune diseases.\nanswer: Chronic inflammatory diseases may cause severe discomfort, but may also be chronic diseases in many cases.\nanswer: Many symptoms involve several diseases.

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How many people get inflammation a year in the United States?

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Around 9 million people have at least one major inflammation annually. Nearly 2 million get arthritis each year. Chronic obstructive pulmonary disease is the leading disease of inflammation in persons with inflammation in the United States. The prevention and suppression of inflammation may reduce lung and other diseases. The prevention, detection, and treatment of acute and chronic inflammatory diseases would reduce lung and other diseases, and might have important health impacts in terms of mortality, morbidity, and disability.

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What are common treatments for inflammation?

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The treatments are effective in reducing both systemic and local symptoms of inflammation. Medication is the principal treatment modality for inflammation, either alone or in conjunction with an adjuvant. Although many studies have shown the efficacy of steroids, the results from this study do not support an "anti-inflammatory" treatment that would prevent or reverse the effects of inflammation-induced injury.

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What is inflammation?

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Inflammation is a complex process involving multiple mechanisms with implications in physiology and pathology and may play an important role in the initiation, perpetuation and maintenance of many inflammatory diseases including RA, SLE, IBD, SSc and AD.

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What are the common side effects of empty (-cigarette sham control)?

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The common side effects observed in the sham-controlled cigarette condition were cough, dyspnea, irritation of the nasal mucosa, headache, nausea, upper respiratory tract irritation, diarrhea, and sinusitis. More than half of the subjects reported a cough/breathing problem. Compared to placebo, smokers experiencing a cigarette sham condition had more coughing and reported greater pain for more than 2 weeks after withdrawal.

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Does empty (-cigarette sham control) improve quality of life for those with inflammation?

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E-CIGS significantly improved all aspects of QoL compared to either smoking or E-CIGS-CIGS and CIGS. This trial reveals a strong evidence of the superiority of E-CIGS and provides a baseline for a randomized full clinical trial of the safety and efficacy of E-CIGS on inflammatory diseases.

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How does empty (-cigarette sham control) work?

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The placebo produced significant responses that were greater in magnitude than were observed using the nicotine-free sham controls. These responses were indicative of an anti-inflammatory effect.

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What are the latest developments in empty (-cigarette sham control) for therapeutic use?

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This review [provides an overview of recent advances in therapeutic VC use] over the last 5 years demonstrates that empty-cigarette sham-controls are safe and effective. The first review to assess safety in a randomized clinical trial in any therapeutic regimen published more than 10 years ago. The availability of multiple sham-control and multiple-period configurations is desirable to ensure a high level of safety and validity. The findings of this review could potentially improve the use of therapeutic VCs in ancillary practice. They also suggest consideration be given for future clinical research on empty-cigarette sham-controls.

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Does inflammation run in families?

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L-Lysine supplementation is able to reduce the clinical and histological severity of inflammation in both mothers and offspring. The mechanism by which it exerts its beneficial effects requires further study.

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Has empty (-cigarette sham control) proven to be more effective than a placebo?

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The data demonstrate that 1.5 hr of 'empty' smoking was more effective than placebo at reducing all of the objective and subjective measures of acute tobacco smoke-related inflammation. This reduction was associated with reductions in the intensity, duration, and overall frequency of acute tobacco smoke-related responses, confirming previous observational data and providing a potential basis for the use of an empty sham control where there is uncertainty over nicotine content or intensity of a cigarette.

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