AsthmaALPSNCT02943161
Asthma L-Citrulline Pilot Study
A study testing L-Citrulline in people with Asthma, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
This study will evaluate whether treatment with L-citrulline, which is an amino acid found in some foods, can increase levels of L-arginine and thereby restore the concentration of nitric oxide (NO) in the airways. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- L-Citrulline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adequate completion of informed consent process with written documentation
- Male and female patients, 18 - 70 years old, inclusive
- Physician diagnosis of asthma (for medical records, ICD 10 coding for physician's diagnosis)
- All racial/ethnic backgrounds may participate
- BMI ≥ 30
- Treatment of controller asthma medication(s) ≥ 4 weeks
- Smoking history ≤10 pack years and no smoking in the last year
- V1 eNO ≤ 30ppb (may be repeated 3x during visit; lowest ppb will be kept)
Who cannot join
- Respiratory tract infection within the 4 weeks prior to the study (may re-enroll after 4 weeks).
- Oral or systemic corticosteroid burst (for any indication) within the 4 weeks
- One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 2-week washout.
- Asthma-related ER visit within the previous 4 weeks of Visit 1
- Significant concomitant medical illness, including (but not limited to)
- Heart disease
Show all 20Show fewer
- Cancer
- Uncontrolled diabetes,
- Chronic renal failure (creatinine > 2.0) at Visit 1 (Associated with higher ADMA levels)
- Untreated sleep apnea
- Other chronic lung/respiratory diseases (COPD, IPF, etc.)
- High dose inhaled steroids (> 1000 mcg/day of Fluticasone or equivalent)
- Current statin use (statins lower ADMA levels); patients may stop statins with approval from their primary physician and enroll after a 6-week washout
- Positive urine pregnancy test at Visit 1 or at any time during the study
- Intolerance or allergy to L-arginine or L-citrulline
- Concomitant use of PDE5 drugs or oral mononitrates
- Participation in an intervention study, use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
- Unable or unlikely to complete study assessments in the opinion of the Investigator
- Study intervention poses undue risk to patient in the opinion of the Investigator
- Breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado
Aurora, Colorado, 80045
Duke University
Durham, North Carolina, 27708
About this study
This study will evaluate whether treatment with L-citrulline, which is an amino acid found in some foods, can increase levels of L-arginine and thereby restore the concentration of nitric oxide (NO) in the airways.
Read the detailed description
Research has shown that some obese asthmatics have a metabolic imbalance in which L-arginine levels are reduced. L-arginine is an amino acid that is used to make NO, a gas that is normally made in the bronchi and ensures that the lungs function properly. In this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of L-citrulline for two weeks. Study participants will be asked to do lung function testing and donate blood before and after taking the supplement. L-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects.
- Conditions
- Asthma
- Being tested
- L-Citrulline
- Keywords
- Obesity, L-citrulline
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CitrullineDietary supplement
The purpose of this study is to see if citrulline supplementation will restore NO levels and lung function in subjects with asthma.
| Study group | Role | What they receive |
|---|---|---|
| L-Citrulline | Experimental | In this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of L-citrulline for two weeks. Study participants will be asked to do lung function testing and donate blood before and after taking the supplement. L-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects. Receives: Dietary Supplement: L-Citrulline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exhaled Nitric Oxide (eNO)
Change in eNO levels before and after treatment with open label L-citrulline at 15g/day
Measured: 2 weeks or 14 days
Secondary outcomes (1)
Change in Plasma L-arginine/ADMA Ratio
Change in L-arginine/ADMA before and after 2 weeks of L-citrulline at 15g/day
Measured: 2 weeks or 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start5 Apr 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Holguin, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943161
- Sponsor's protocol ID
- 16-2041
- Acronym
- ALPS
- Status last verified
- Feb 2020
- First submitted
- 21 Oct 2016
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing de-identified data with co-investigators approved by the IRB and Duke University
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma L-Citrulline Pilot Study
- ClinicalTrials.gov ID
- NCT02943161
- Acronym / sponsor ID
- ALPS / 16-2041
- Conditions
- Asthma
- Keywords
- Obesity, L-citrulline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether treatment with L-citrulline, which is an amino acid found in some foods, can increase levels of L-arginine and thereby restore the concentration of nitric oxide (NO) in the airways.
Detailed description
Research has shown that some obese asthmatics have a metabolic imbalance in which L-arginine levels are reduced. L-arginine is an amino acid that is used to make NO, a gas that is normally made in the bronchi and ensures that the lungs function properly. In this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of L-citrulline for two weeks. Study participants will be asked to do lung function testing and donate blood before and after taking the supplement. L-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-Citrulline | Experimental | Dietary Supplement: L-CitrullineIn this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of L-citrulline for two weeks. Study participants will be asked to do lung function testing and donate blood before and after taking the supplement. L-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adequate completion of informed consent process with written documentation
- Male and female patients, 18 - 70 years old, inclusive
- Physician diagnosis of asthma (for medical records, ICD 10 coding for physician's diagnosis)
- All racial/ethnic backgrounds may participate
- BMI ≥ 30
Key exclusion criteria (20 listed)
- Respiratory tract infection within the 4 weeks prior to the study (may re-enroll after 4 weeks).
- Oral or systemic corticosteroid burst (for any indication) within the 4 weeks
- One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 2-week washout.
- Asthma-related ER visit within the previous 4 weeks of Visit 1
- Significant concomitant medical illness, including (but not limited to)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CitrullineThe purpose of this study is to see if citrulline supplementation will restore NO levels and lung function in subjects with asthma. | Dietary supplement | L-Citrulline |
Primary outcome
Change in Exhaled Nitric Oxide (eNO)
Time frame: 2 weeks or 14 days
Change in eNO levels before and after treatment with open label L-citrulline at 15g/day
1 secondary outcome
Change in Plasma L-arginine/ADMA Ratio
Time frame: 2 weeks or 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: Yes. Sharing de-identified data with co-investigators approved by the IRB and Duke University
Related trials for Asthma
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Asthma, Atherosclerosis
Not yet recruitingObservational study
Prevelance of Broncial Asthma and Allergic Rhinitis in Children With Nephrotic Syndrim
Bronchial Asthma, Allergic Rhinitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Holguin, MD, MPH principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Citrulline in people with Asthma, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exhaled Nitric Oxide (eNO) (time frame: 2 weeks or 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.