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Corticosteroid

Prednisone for Airway Inflammation (Smokisone Trial)

Phase 1 & 2

Recruiting

Led By Terry Noah, 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

No history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician-diagnosed asthma.

Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Smokisone Trial Summary

This trial is testing whether an oral steroid can reduce airway inflammation caused by inhaling wood smoke particles.

Who is the study for?

Healthy adults aged 18-45, both genders, with good lung function and no history of significant chronic diseases or asthma. Participants must not be pregnant, have had a recent fever or infection, take immunosuppressive drugs (except oral contraceptives), or smoke heavily. They should be able to exercise on a bicycle and provide sputum samples.Check my eligibility

What is being tested?

The study is testing if Prednisone, an oral steroid medication, can reduce airway inflammation caused by inhaling wood smoke particles during a controlled exposure scenario involving intermittent cycling and rest for two hours.See study design

What are the potential side effects?

Prednisone may cause side effects such as mood swings, increased appetite, high blood pressure, sleep problems and potential increase in risk of infections due to its immune-suppressing properties.

Smokisone Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had asthma or symptoms like wheezing or chest tightness.

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I am not pregnant or have had a hysterectomy with oophorectomy.

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I can provide a sputum sample when asked.

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I am between 18 and 45 years old.

Smokisone Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours 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 From Baseline to 24 Hours in Sputum Percent Neutrophils

Change From Baseline to 4 Hours in Sputum Percent Neutrophils

Secondary outcome measures

Change in IL-1b

Change in IL-6

Change in IL-8

+4 more

Other outcome measures

Mucociliary Clearance (MCC)

Smokisone Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Prednisone, then PlaceboActive Control2 Interventions

Group II: Placebo, then PrednisonePlacebo Group2 Interventions

0 / 4Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,191,028 Total Patients Enrolled

4 Trials studying Bronchitis

3,106 Patients Enrolled for Bronchitis

United States Department of DefenseFED

865 Previous Clinical Trials

327,685 Total Patients Enrolled

Terry Noah, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

7 Previous Clinical Trials

342 Total Patients Enrolled

Media Library

Prednisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03861390 — Phase 1 & 2

Bronchitis Research Study Groups: Placebo, then Prednisone, Prednisone, then Placebo

Bronchitis Clinical Trial 2023: Prednisone Highlights & Side Effects. Trial Name: NCT03861390 — Phase 1 & 2

Prednisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03861390 — Phase 1 & 2

Frequently Asked Questions

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

Is there still capacity to join this research study?

"As indicated on clinicaltrials.gov, this experiment is currently accepting participants. It was officially announced on March 22nd 2019 and last revised on July 28th 2022."

Answered by AI

What pathological conditions is this therapy commonly employed to alleviate?

"Thyroiditis, ulcerative colitis and various forms of cancer are all conditions that may respond to this therapy."

Answered by AI

Is this research program open to participants within the younger age demographic?

"This trial is open to adult participants between 18 and 45 years old. In contrast, there are 87 studies for underage individuals and 546 research projects dedicated to elderly patients."

Answered by AI

Could I be considered a viable candidate for this research endeavor?

"This clinical trial is currently seeking 14 volunteers aged 18 to 45 who are exhibiting signs of inflammation. Candidates must have a documented oxidation saturation rate of at least 93%, FEV1/FVC ratio higher than 0,70 and no past episodes of wheezing or chest tightness consistent with asthma diagnosis. Furthermore, participants need to provide evidence that they were vaccinated against Covid-19, pass the pregnancy test for females who weren't surgically sterilized yet and demonstrate an increase in sputum percentage due to inhaled WSP administration during separate protocol testing session."

Answered by AI

Are there any prior experiments that have utilized this treatment option?

"As of the present, there are 334 active studies concerning this medication. Out of those trials, 92 have progressed to Phase 3 testing and most take place in Duarte, California. That said, a total of 16403 clinical trial sites across the world are involved with this treatment's testing protocols."

Answered by AI

How many participants are currently included in this clinical trial?

"Affirmative. According to the information accessible on clinicaltrials.gov, this trial has yet again opened for recruitment since its posting date of March 22nd 2019 and most recent update from July 28th 2022 . The study is seeking 14 participants from a single site."

Answered by AI

Recent research and studies

Annals of Allergy, Asthma & ImmunologyJournal

Development of an Inhaled Endotoxin Challenge Protocol for Characterizing Evoked Cell Surface Phenotype and Genomic Responses of Airway Cells in Allergic Individuals

Alexis, Neil E., Willie June Brickey, John C. Lay, Ying Wang, Robert A.S. Roubey, Jenny P.-Y. Ting, and David B. Peden. 2008. “Development of an Inhaled Endotoxin Challenge Protocol for Characterizing Evoked Cell Surface Phenotype and Genomic Responses of Airway Cells in Allergic Individuals”. Annals of Allergy, Asthma & Immunology. Elsevier BV. doi:10.1016/s1081-1206(10)60444-9.

Journal of Allergy and Clinical ImmunologyJournal

IL-1 Receptor Antagonist Reduces Endotoxin-induced Airway Inflammation in Healthy Volunteers

Hernandez, Michelle L., Katherine Mills, Martha Almond, Krista Todoric, Maria M. Aleman, Hongtao Zhang, Haibo Zhou, and David B. Peden. 2015. “IL-1 Receptor Antagonist Reduces Endotoxin-induced Airway Inflammation in Healthy Volunteers”. Journal of Allergy and Clinical Immunology. Elsevier BV. doi:10.1016/j.jaci.2014.07.039.

ChestJournal

Elevated Airway Purines in COPD

Esther, Charles R., Jr, Aili L. Lazaar, Elena Bordonali, Bahjat Qaqish, and Richard C. Boucher. 2011. “Elevated Airway Purines in COPD”. Chest. Elsevier BV. doi:10.1378/chest.10-2471.

Military MedicineJournal