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:
- Are not pregnant
- Have been diagnosed with asthma by a healthcare provide at least 6 months ago
- Are currently taking an ICS or ICS/LABA medication such as Symbicort, Pulmicort, Advair, or QVar
- Have a BMI greater than 30
For more information about who can join this study, please contact the study team at DukeAirwayResearch@duke.edu or 919-479-0861.
- Are not pregnant
- Have been diagnosed with asthma by a healthcare provide at least 6 months ago
- Are currently taking an ICS or ICS/LABA medication such as Symbicort, Pulmicort, Advair, or QVar
- Have a BMI greater than 30
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:
- Answer questionnaires
- Have your lung function tested
- Give blood and urine samples
- Undergo methacholine challenges (breathing tests to test your airways)
Study Dosing Period: During this period of the study, you will:
- Be randomized (like flipping a coin) to 1 of 2 groups
-- One group will take the study drug (L-citrulline) by mixing a powder into water once a day for 7 weeks
-- The other group will take a placebo (sugar powder) by mixing the powder into water once a day for 7 weeks
- Complete an asthma questionnaire 4 weeks after your first dose
- Complete breathing tests before and after taking the first and last dose of the study drug/placebo
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.
- Answer questionnaires
- Have your lung function tested
- Give blood and urine samples
- Undergo methacholine challenges (breathing tests to test your airways)
Study Dosing Period: During this period of the study, you will:
- Be randomized (like flipping a coin) to 1 of 2 groups
-- One group will take the study drug (L-citrulline) by mixing a powder into water once a day for 7 weeks
-- The other group will take a placebo (sugar powder) by mixing the powder into water once a day for 7 weeks
- Complete an asthma questionnaire 4 weeks after your first dose
- Complete breathing tests before and after taking the first and last dose of the study drug/placebo
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 ACCRUAL