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New treatment option for Asthma
Official title Obesity, Metabolic Dysregulation and the Airway Epithelium in Asthmatics
ClinicalTrials.gov ID: NCT03215836
What this study is testing
- What it's testing
- The objective of this pilot study is to determine whether obesity and metabolic syndrome are in fact synergistic in relation to airway nitric oxide (NO) biology. To do so, the investigators want to determine how obesity and the metabolic syndrome relate to metabolism in bronchial airway epithelial cells and the nasal epithelium.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- For ALL Groups
- Adequate completion of informed consent process with written documentation
- Male and female patients, ≥ 18 - 65 years old
- Smoking history \<10 pack years and no smoking in the last year \ \ people can be included in the study if they are on blood pressure treatment and...
- Specific to Asthma Groups i. From all racial/ethnic backgrounds with a diagnosis of asthma based on physician diagnosis for \>6 months
You likely can't join if
- (all groups):
- Significant or uncontrolled concomitant medical illness (PI discretion) including, but not limited to heart disease, cancer, diabetes (HbAc1 \> 6.5)...
- Chronic renal failure (creatinine \> 2.0) at screening (associated with higher asymmetric dimethylarginine (ADMA) levels);
- Current statins use (statins lower ADMA levels);
- On diabetic medications;
- Positive pregnancy test;
See the full eligibility criteria
- For ALL Groups
- Adequate completion of informed consent process with written documentation
- Male and female patients, ≥ 18 - 65 years old
- Smoking history \<10 pack years and no smoking in the last year \ \ people can be included in the study if they are on blood pressure treatment and are on a diet control/exercise only treatment of diabetes.
- Specific to Asthma Groups i. From all racial/ethnic backgrounds with a diagnosis of asthma based on physician diagnosis for \>6 months
- Specific to Metabolic Syndrome Group. Metabolic syndrome diagnosis based on having at least any three of: a. Triglycerides ≥ 150 mg/dl; b. High-density lipoproteins (HDL) cholesterol ≤ 50 mg/dl for women and ≤ 40 mg/dl...
- Specific to Non-Metabolic Syndrome Group a. Baseline pre-bronchodilator forced expiratory volume (FEV1) of 50% or greater of predicted with a 12% or greater bronchodilator (BD) response to 4 puffs of albuterol or PC20...
- Specific to Non-Obese Group a. Body Mass Index (BMI) \< 30 b. Specific to Non-Asthma Group i. No history of asthma or any other airway diseases; ii. Pulmonary function test within normal limits; iii. BMI ≥ 30.
- (all groups):
- Significant or uncontrolled concomitant medical illness (PI discretion) including, but not limited to heart disease, cancer, diabetes (HbAc1 \> 6.5), renal disease (creatinine \> 2.0) at Visit 0, neurological (brain...
- Chronic renal failure (creatinine \> 2.0) at screening (associated with higher asymmetric dimethylarginine (ADMA) levels);
- Current statins use (statins lower ADMA levels);
- On diabetic medications;
- Positive pregnancy test;
- Positive urine cotinine and/or urine tetrahydrocannabinol (THC) test;
- Current or recent (within 30 days) investigational treatment or participation in another treatment research study (including non-pharmacologic interventions);
- Unable or unlikely to complete study assessments or the study intervention (i.e. bronchoscopy) poses undue risk to patient in the opinion of the investigator. a. Specific to Asthma Groups i. Respiratory tract infection...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.