Trial Outcomes & Findings for Effects of L-arginine Supplementation in Adults With Moderate to Severe Asthma (NCT NCT00280683)

NCT ID: NCT00280683

Last Updated: 2017-05-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2017-05-30

Participant Flow

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.

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.

Participant milestones

Measure	Arginine 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.	Placebo 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.
Overall Study STARTED	10	10
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Arginine 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.	Placebo 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.
Overall Study Withdrawal by Subject	1	2
Overall Study Adverse Event	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arginine n=10 Participants 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 n=10 Participants Placebo intervention	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	53.1 years STANDARD_DEVIATION 15.4 • n=5 Participants	50.8 years STANDARD_DEVIATION 15.1 • n=7 Participants	52.0 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
FEV1 Percent Predicted	75 Percent STANDARD_DEVIATION 17.5 • n=5 Participants	70.8 Percent STANDARD_DEVIATION 18.5 • n=7 Participants	72.9 Percent STANDARD_DEVIATION 18.0 • n=5 Participants
Exhaled Nitric oxide	28.2 ppb (parts per billion) STANDARD_DEVIATION 16.4 • n=5 Participants	24.4 ppb (parts per billion) STANDARD_DEVIATION 17.6 • n=7 Participants	26.3 ppb (parts per billion) STANDARD_DEVIATION 17 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Our original power analysis was based on an expected minor exacerbation rate of 3-4 per month.

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.

Outcome measures

Measure	Arginine n=10 Participants The L-arginine 1g tablets were from Jarrow formulas (Los Angeles, CA). The name of these tablets is Arginine 1000.	Placebo n=10 Participants Matching placebo tablets were made by Jarrow Formulas.
Number of Asthma Exacerbations in Three Months	30 exacerbations	31 exacerbations

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Measure	Arginine n=10 Participants The L-arginine 1g tablets were from Jarrow formulas (Los Angeles, CA). The name of these tablets is Arginine 1000.	Placebo n=10 Participants Matching placebo tablets were made by Jarrow Formulas.
L-arginine Serum Concentration	0.002 pmol/100ul Standard Error 0.0006	0.0011 pmol/100ul Standard Error 0.0002

Adverse Events

Arginine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arginine n=10 participants at risk L-arginine 1 g tablets were made by Jarrow Formulas.	Placebo n=10 participants at risk Matching placebo tablets were purchased from Jarrow Formulas.
Cardiac disorders Hypertension	0.00% 0/10 • 1 year intervals	10.0% 1/10 • Number of events 1 • 1 year intervals

Additional Information

Dr. Nicholas Kenyon

UCaliforniaDavis

Phone: 916-734-3564

Email: njkenyon@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place