Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280683
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-01-19
Brief Title:
Effects of L-arginine Supplementation in Adults With Moderate to Severe Asthma
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Phase 2 Study GCRC Effects of L-arginine Supplementation on Exhaled Nitric Oxide and Clinical Exacerbations in Adults With Moderate to Severe Asthma
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
The primary objective of this 3 month clinical study is to determine if supplemental L-arginine can decrease the number of asthma exacerbations in patients with severe asthma L-arginine a natural amino acid produces nitric oxide NO when it is converted to L-citrulline in the presence of the nitric oxide synthase enzymes We and others have found that NO can protect against allergic airway inflammation airway hyperresponsiveness and airway fibrosis in various animal models In addition we have found that arginase I expression correlates strongly with the lymphocyte and eosinophil influx into the lung and this enzyme may regulate the airway inflammatory response Our central hypothesis is that L-arginine will increase NO levels in the lung and decrease the number of acute exacerbations of asthma It may do this by either decreasing the number of Th2 lymphocytes or down-regulating arginase I expression or both
Our specific aims are therefore
1 To test the hypothesis in a randomized double-blinded placebo controlled trial that 3 months of L-arginine supplementation will decrease the number of acute asthma exacerbations in severe asthmatic patients
2 To determine whether L-arginine decreases the ratio of peripheral blood Th2 to Th1 lymphocytes and
3 To determine whether L-arginine will modulate serum arginase III levels and their downstream products
Patients will be recruited primarily from the UC Davis Asthma Network UCAN clinics which focus on the care of severe asthmatics and the study will be performed at the UC DavisVA General Clinical Research Center
Our specific aims are therefore
1 To test the hypothesis in a randomized double-blinded placebo controlled trial that 3 months of L-arginine supplementation will decrease the number of acute asthma exacerbations in severe asthmatic patients
2 To determine whether L-arginine decreases the ratio of peripheral blood Th2 to Th1 lymphocytes and
3 To determine whether L-arginine will modulate serum arginase III levels and their downstream products
Patients will be recruited primarily from the UC Davis Asthma Network UCAN clinics which focus on the care of severe asthmatics and the study will be performed at the UC DavisVA General Clinical Research Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K30-04-Z001 | OTHER | UC Davis | httpsreporternihgovquickSearchUL1RR024146 |
| UL1RR024146 | NIH | None | None |