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Asthma L-Citrulline Pilot Study (ALPS)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-Citrulline
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Obesity, L-citrulline

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
    • 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

Sites / Locations

  • University of Colorado
  • Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

L-Citrulline

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Exhaled Nitric Oxide (eNO)
Change in eNO levels before and after treatment with open label L-citrulline at 15g/day

Secondary Outcome Measures

Change in Plasma L-arginine/ADMA Ratio
Change in L-arginine/ADMA before and after 2 weeks of L-citrulline at 15g/day

Full Information

First Posted
October 21, 2016
Last Updated
February 25, 2020
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02943161
Brief Title
Asthma L-Citrulline Pilot Study
Acronym
ALPS
Official Title
Asthma L-Citrulline Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Obesity, L-citrulline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-Citrulline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
L-Citrulline
Intervention Description
The purpose of this study is to see if citrulline supplementation will restore NO levels and lung function in subjects with asthma.
Primary Outcome Measure Information:
Title
Change in Exhaled Nitric Oxide (eNO)
Description
Change in eNO levels before and after treatment with open label L-citrulline at 15g/day
Time Frame
2 weeks or 14 days
Secondary Outcome Measure Information:
Title
Change in Plasma L-arginine/ADMA Ratio
Description
Change in L-arginine/ADMA before and after 2 weeks of L-citrulline at 15g/day
Time Frame
2 weeks or 14 days
Other Pre-specified Outcome Measures:
Title
Change in Asthma Control Score
Description
Change in asthma control scores (ACQ)
Time Frame
2 weeks or 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Holguin, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing de-identified data with co-investigators approved by the IRB and Duke University

Learn more about this trial

Asthma L-Citrulline Pilot Study

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