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

NCT00280683 | Completed Phase 2 Results DMC

• 3 other identifiers: 200412788UL1RR024146K30-04-Z001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a protective role in patients with moderate to severe asthma. The investigators believe that a natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma exacerbations and improve the asthma care of moderate to severe asthma patients. This study is a randomized, placebo controlled trial in which subjects will receive either 3 months of L-arginine supplementation or a placebo. The investigators will monitor subjects' symptoms, the number of asthma exacerbations, and lung function. In addition, we will draw blood, obtain induced sputum samples and measure exhaled breath nitric oxide levels at each monthly visit.

Conditions

Asthma

Keywords

Airway Inflammation; Moderate persistent asthma; Severe Persistent Asthma

Outcome Measures

Primary Outcomes (1)

• Number of Asthma Exacerbations in Three Months

  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.

  3 months

Secondary Outcomes (1)

• L-arginine Serum Concentration

  90 days

Study Arms (2)

Arginine

ACTIVE COMPARATOR

Enrolled subjects will take L-arginine orally, at 0.1 g/kg/day. Subjects will take three to four 1 g capsules (based on weight) of L-arginine twice daily for three months. L-arginine capsules were obtained from Jarrow Pharmaceuticals.

Drug: L-arginine

Placebo

PLACEBO COMPARATOR

Enrolled subjects took three to four placebo capsules that matched color and size of the intervention twice daily for three months. Matching placebo capsules were obtained from Jarrow Pharmaceuticals.

Drug: Placebo

Interventions

L-arginine DRUG

subjects will take matching 0.01 g/kg/day of L-arginine in divided doses for thre months.

Also known as: Arginine 1000

Arginine

Placebo DRUG

Placebo tablets that match the L-arginine intervention tablets will be given for three months

Also known as: Matching placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe persistent asthma
• Subject is stable on same asthma medications for at least one month
• If the subject is a woman of child-bearing age, a negative pregnancy test

You may not qualify if:

• Less than 18 yrs/ age
• Baseline Forced Expiratory Volume in 1 second (FEV1) \<40% predicted
• Known or suspected allergy to L-arginine
• Pregnant women, nursing women, or women actively trying to achieve pregnancy
• Current smokers
• Subjects with more than a 15 pack-year history of smoking

Sponsors & Collaborators

• University of California, Davis: lead
• National Institutes of Health (NIH): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

University of California, Davis General Clinical Research Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Arginine

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Results Point of Contact

• Title: Dr. Nicholas Kenyon
• Organization: UCaliforniaDavis

njkenyon@ucdavis.edu

916-734-3564

Study Officials

• Nicholas Kenyon, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2006
• First Posted: January 23, 2006
• Study Start: December 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 30, 2017
• Results First Posted: June 5, 2013

Record last verified: 2017-05

Locations

US (1)