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GSNO Challenge for Severe Asthma
Phase < 1
Recruiting
Led By Kristie Ross, MD
Research Sponsored by James Reynolds
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For subjects with Asthma: Physician diagnosis of asthma for at least one year
For Healthy Volunteers: Adult males or females age ≥ 18 and ≤ 50 years at time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial is testing whether or not the GSNO Challenge test is a reliable way to measure GSNOR activity. The trial will also study the phenotypes of asthma patients with increased GSNOR activity.
Who is the study for?
This trial is for adults aged 18-50 with a physician's diagnosis of asthma for at least one year, non-smokers, and have certain lung function test results. Healthy volunteers without chronic lung diseases or severe allergies can also participate. People with recent corticosteroid use, infections, high BMI, other chronic diseases, smoking history or those who are pregnant/breastfeeding cannot join.Check my eligibility
What is being tested?
The study tests a new GSNO Challenge diagnostic method to identify increased GSNOR enzyme activity in the airways which may affect asthma. Participants will inhale an investigational drug called GSNO that isn't FDA-approved yet but could lead to personalized asthma treatments.See study design
What are the potential side effects?
Since this is an investigational study involving inhalation of GSNO, potential side effects aren't fully known but may include respiratory irritation or reactions related to bronchoscopy procedures used in testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with asthma by a doctor for at least one year.
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I am between 18 and 50 years old and consider myself healthy.
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My lung function after asthma treatment is more than 55% of what's expected.
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I have never had asthma, COPD, or any chronic lung disease.
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I do not have asthma, COPD, or any chronic lung disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Airway GSNOR comparison
Secondary outcome measures
Fractional Exhaled Nitric Oxide (FeNO) levels changes
Trial Design
1Treatment groups
Experimental Treatment
Group I: GSNOR Challenge testingExperimental Treatment1 Intervention
patient will use a nebulizer to inhale (breathe in) a solution of GSNO followed by repeated measurements of airway function (breathing tests)
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Who is running the clinical trial?
James ReynoldsLead Sponsor
2 Previous Clinical Trials
44 Total Patients Enrolled
University Hospitals Cleveland Medical CenterOTHER
317 Previous Clinical Trials
340,197 Total Patients Enrolled
4 Trials studying Asthma
700 Patients Enrolled for Asthma
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,890 Total Patients Enrolled
6 Trials studying Asthma
4,820 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have smoked the equivalent of a pack a day for 5 years.I have a lung condition like cystic fibrosis or COPD that may affect my study participation.I have been diagnosed with asthma by a doctor for at least one year.You do not smoke.My creatinine level is higher than 1.8 mg/dl.I am between 18 and 50 years old and consider myself healthy.I've had more than 3 flare-ups of my condition in the last 6 months.I am currently taking blood thinners like warfarin or heparin.I do not currently have COVID-19 or any acute viral symptoms.If you have asthma, you should not smoke.My lung function after asthma treatment is more than 55% of what's expected.I don't have any health issues that could make this study riskier for me.I am between 18 and 50 years old and have asthma.I haven't taken antibiotics for an infection in the last 14 days.I have needed steroids for my asthma in the last month.Your body mass index (BMI) is higher than 45.You were born before 35 weeks of pregnancy.I have diabetes (type 1 or type 2).I have a blood disorder that affects clotting or oxygen delivery.I was put on a breathing machine for asthma in the last year.I have a condition or throat issue that makes bronchoscopy risky.You have other long-term health issues such as heart, lung, kidney, liver, or brain problems, or any other serious health conditions that make you unsuitable for the study.I am currently taking beta-blockers, antidepressants, meperidine, or nitrates.I have never had asthma, COPD, or any chronic lung disease.My asthma shows significant improvement with a bronchodilator or I have a specific methacholine test result.Your blood pressure is not between 90-180 mm Hg (top number) and 50-100 mm Hg (bottom number) when checked at the screening.I cannot or will not stop taking my medications before specific tests.I have asthma.I do not have asthma, COPD, or any chronic lung disease.I cannot do consistent breathing tests.I am allergic to anesthesia used in bronchoscopy.
Research Study Groups:
This trial has the following groups:- Group 1: GSNOR Challenge testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are persons who are thirty years or older being considered for this clinical experiment?
"This clinical trial is open to individuals aged 18 or older and under 50 years of age."
Answered by AI
Are applications being accepted at the moment for this research project?
"The medical trial, which was initially posted on April 30th 2019 and recently updated as of February 24th 2022, is actively seeking participants. Data hosted on clinicaltrials.gov attests to this fact."
Answered by AI
How many participants are engaged in this investigation?
"Affirmative, the clinicaltrials.gov web page displays that this experiment is still searching for participants. It was initially posted on April 30th 2019 and last revised on February 24th 2022. The medical trial requires 60 people to be enrolled from 2 distinct sites."
Answered by AI
Who meets the criteria to join this clinical research?
"This trial seeks to enrol 60 adults, aged 18-50 years old, who suffer from asthma. Necessary requirements include no history of atopic or allergic diseases necessitating immunotherapy and/or immune modulators; clinical diagnosis of the condition for a year prior to study entry; airway reversibility after bronchodilator treatment >12%; methacholine PC20 <16 mg/ml; post maximal FEV1 >55% of predicted value; being non-smokers with no chronic pulmonary disease such as COPD or other respiratory illness."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
University Hospitals Cleveland Medical Center
Indiana University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
sJournal
Phenotype of Asthmatics with Increased Airway <i>s</i>-nitrosoglutathione Reductase ActivityOther Trials to Consider
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