Purpose of this Study
We are doing this study to find out if L-citrulline (the study drug) will help improve asthma symptoms when taken daily. This study is important because managing symptoms of asthma can improve quality of life and long-term health.
Who Can Participate?
Eligibility
Adults ages 18-65 who:<ul>
<li>Are not pregnant</li>
<li>Have been diagnosed with asthma by a healthcare provide at least 6 months ago</li>
<li>Are currently taking an ICS or ICS/LABA medication such as Symbicort, Pulmicort, Advair, or QVar</li>
<li>Have a BMI greater than 30</li></ul>
For more information about who can join this study, please contact the study team at DukeAirwayResearch@duke.edu or 919-479-0861.
<li>Are not pregnant</li>
<li>Have been diagnosed with asthma by a healthcare provide at least 6 months ago</li>
<li>Are currently taking an ICS or ICS/LABA medication such as Symbicort, Pulmicort, Advair, or QVar</li>
<li>Have a BMI greater than 30</li></ul>
For more information about who can join this study, please contact the study team at DukeAirwayResearch@duke.edu or 919-479-0861.
Age Range
18-65
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
If you choose to join this study, you will:<ul>
<li>Answer questionnaires</li>
<li>Have your lung function tested</li>
<li>Give blood and urine samples</li>
<li>Undergo methacholine challenges (breathing tests to test your airways)</li></ul>
Study Dosing Period: During this period of the study, you will get a random assignment (like flipping a coin) to 1 of 2 groups:<ul>
<li>One group will take the study drug (L-citrulline) by mixing a powder into water once a day for 7 weeks</li>
<li>The other group will take a placebo (sugar powder) by mixing the powder into water once a day for 7 weeks</li></ul>
All study participants will:<ul>
<li>Complete an asthma questionnaire 4 weeks after your first dose</li>
<li>Complete breathing tests before and after taking the first and last dose of the study drug/placebo</li></ul>
You also have the option to participate in a bronchoscopy where cells from your lungs will be collected to study how well L-citrulline works.
<li>Answer questionnaires</li>
<li>Have your lung function tested</li>
<li>Give blood and urine samples</li>
<li>Undergo methacholine challenges (breathing tests to test your airways)</li></ul>
Study Dosing Period: During this period of the study, you will get a random assignment (like flipping a coin) to 1 of 2 groups:<ul>
<li>One group will take the study drug (L-citrulline) by mixing a powder into water once a day for 7 weeks</li>
<li>The other group will take a placebo (sugar powder) by mixing the powder into water once a day for 7 weeks</li></ul>
All study participants will:<ul>
<li>Complete an asthma questionnaire 4 weeks after your first dose</li>
<li>Complete breathing tests before and after taking the first and last dose of the study drug/placebo</li></ul>
You also have the option to participate in a bronchoscopy where cells from your lungs will be collected to study how well L-citrulline works.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
SANDIA: Supplementing L-citrulline to overweight late Asthma oNset phenotypes to increase airway L-arginine/ADMA ratio and Improve Asthma control
Study Website
Principal Investigator
Loretta
Que
Protocol Number
PRO00104357
NCT ID
NCT03885245
Phase
Pilot
Enrollment Status
Open to Enrollment