Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of L-arginine Supplementation in Adults With Moderate to Severe Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00280683
Recruitment Status : Completed
First Posted : January 23, 2006
Results First Posted : June 5, 2013
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: L-arginine
Drug: Placebo
Enrollment 20
Recruitment Details Between 2006-2008, moderate to severe persistent asthma patients, as defined by the NAEPP Expert Panel Reports, were eligible for enrollment [10]. Most subjects were recruited from the UC Davis Asthma Network clinics, which are referral clinics for patients with difficult to control asthma.
Pre-assignment Details The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6–10 g/day) and placebo were done by the UC Davis Investigational Drug Service.Eligible subjects had documented moderate to severe persistent asthma, were at least 18 years of age, not pregnant, and able to give consent.
Arm/Group Title Arginine Placebo
Hide Arm/Group Description 2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. 2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
Period Title: Overall Study
Started 10 10
Completed 8 [1] 7
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             1             2
Adverse Event             1             1
[1]
Reasons for subjects discontinuing included inability to adhere to the schedule or adverse event.
Arm/Group Title Arginine Placebo Total
Hide Arm/Group Description 2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study. Placebo intervention Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  90.0%
9
  90.0%
18
  90.0%
>=65 years
1
  10.0%
1
  10.0%
2
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
53.1  (15.4) 50.8  (15.1) 52.0  (15.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
8
  80.0%
8
  80.0%
16
  80.0%
Male
2
  20.0%
2
  20.0%
4
  20.0%
FEV1 Percent Predicted  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 10 participants 10 participants 20 participants
75  (17.5) 70.8  (18.5) 72.9  (18.0)
Exhaled Nitric oxide   [1] 
Mean (Standard Deviation)
Unit of measure:  Ppb (parts per billion)
Number Analyzed 10 participants 10 participants 20 participants
28.2  (16.4) 24.4  (17.6) 26.3  (17)
[1]
Measure Description: The secondary clinical endpoints that were measured included the patient symptom diary, daily short acting β-agonist use, St. George’s Respiratory questionnaire, daily PEF diary, forced expiratory volume in one second (FEV1), and forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) measurements performed at the monthly visits, exhaled NO concentration and induced sputum eosinophil percent counts
1.Primary Outcome
Title Number of Asthma Exacerbations in Three Months
Hide Description Asthma exacerbation is a composite endpoint. An asthma exacerbation is defined as any of the following: a) a drop in the morning peak expiratory flow rate (PEF) >30% from baseline on 2 consecutive days, b) a need for initiation of or increased dose of inhaled corticosteroids, or the c) doubling of short-acting rescue β-agonist drug use (e.g.Albuterol) on two consecutive days. Any one of these three counts as one asthma exacerbation.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Our original power analysis was based on an expected minor exacerbation rate of 3-4 per month.
Arm/Group Title Arginine Placebo
Hide Arm/Group Description:
The L-arginine 1g tablets were from Jarrow formulas (Los Angeles, CA). The name of these tablets is Arginine 1000.
Matching placebo tablets were made by Jarrow Formulas.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: exacerbations
30 31
2.Secondary Outcome
Title L-arginine Serum Concentration
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arginine Placebo
Hide Arm/Group Description:
L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
Matching placebo tablets were disbursed by the Investigational Drug Service.
Overall Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: pmol/100ul
0.002  (0.0006) 0.0011  (0.0002)
Time Frame 1 year intervals
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arginine Placebo
Hide Arm/Group Description L-arginine 1 g tablets were made by Jarrow Formulas. Matching placebo tablets were purchased from Jarrow Formulas.
All-Cause Mortality
Arginine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arginine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arginine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/10 (10.00%)    
Cardiac disorders     
Hypertension * [1]  0/10 (0.00%)  0 1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One subject in the placebo group was unblinded from the study and discontinued from study drug because of an increased in blood pressure. Blood pressure returned to normal.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Nicholas Kenyon
Organization: UCaliforniaDavis
Phone: 916-734-3564
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00280683     History of Changes
Other Study ID Numbers: 200412788
UL1RR024146 ( U.S. NIH Grant/Contract )
K30-04-Z001 ( Other Identifier: UC Davis )
First Submitted: January 19, 2006
First Posted: January 23, 2006
Results First Submitted: December 6, 2012
Results First Posted: June 5, 2013
Last Update Posted: May 30, 2017