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L-Citrulline for Asthma (SEALS Trial)

Phase 2

Recruiting

Led By Fernando Holguin, MD, MPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suboptimal asthma control at baseline (ACQ ≥ 0.5 or ACT<19)

Smoking tobacco history ≤15 pack years and no smoking in the last 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 22 weeks

Awards & highlights

SEALS Trial Summary

This trial is studying whether an amino acid called L-citrulline can improve lung function and asthma control in obese patients with deployment related asthma.

Who is the study for?

This trial is for military personnel aged 18-70 who developed asthma after deployment post-9/11. Participants must have a history of smoking less than or equal to 15 pack years, no recent smoking, and show signs of suboptimal asthma control. Pregnant individuals, those on recent corticosteroids or with significant illnesses like heart disease or uncontrolled diabetes are excluded.Check my eligibility

What is being tested?

The study tests if L-citrulline supplementation can improve lung function in patients with deployment-related asthma by increasing airway nitric oxide levels. It's compared against a placebo in a controlled setting to see if it offers an effective add-on therapy for better asthma management.See study design

What are the potential side effects?

Potential side effects may include intolerance reactions similar to allergies due to L-citrulline or digestive issues since it's an amino acid supplement. However, the exact side effects will be monitored as part of the study.

SEALS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My asthma is not well-controlled.

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I have smoked 15 or fewer pack-years and haven't smoked in the last 3 months.

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I am between 18 and 70 years old.

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I have asthma symptoms that started after military service in Southwest Asia post-9/11.

SEALS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 22 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 22 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 22 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Asthma Control Questionnaire

Apo-Feno-Micro

Side effects data

From 2019 Phase 3 trial • 189 Patients • NCT02891837

19%

Pyrexia

16%

Pain

14%

Restlessness

12%

Hypokalaemia

12%

Tachycardia

12%

Pleural effusion

12%

Hypertension

11%

Constipation

Atelectasis

Haemoglobin decreased

Hypocalcaemia

Hypotension

Oligurea

Vomiting

Electrolyte imbalance

Stridor

Pulmonary oedema

Chylothorax

Tachypnoea

Coagulation time prolonged

C-reactive protein increased

Metabolic acidosis

Pulmonary congestion

Anaemia

Cough

Diarrhoea

Sinus bradycardia

Blood creatine phosphokinase increased

Blood lactate dehydrogenase increased

Leukopenia

Atrioventricular block complete

Cardiac output decreased

Thrombocytopenia

Oedema peripheral

Arrhythmia

Cardiac failure

Adrenal insufficiency

Hypoalbuminaemia

Aortic valve incompetence

Post procedural haemorrhage

Haematocrit decreased

Aspartate aminotransferase increased

Staphylococcal infection

Nausea

Cardiac tamponade

Ventricular fibrillation

Blood lactic acid increased

Ventricular tachycardia

Junctional ectopic tachycardia

Swallow study abnormal

Coagulopathy

Leukocytosis

Atrioventricular block

Supraventricular extrasystoles

Hypothermia

Oedema

Peripheral swelling

Secretion discharge

Respiratory arrest

Hypomagnesaemia

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

L-citrulline - All Patients

L-citrulline - All Patients on Mechanical Ventilation for ≤48 Hours

L-citrulline - US Patients on Mechanical Ventilation for >48 Hours

Placebo - All Patients

L-citrulline - US Patients on Mechanical Ventilation for ≤48 Hours

L-citrulline - All Patients on Mechanical Ventilation for >48 Hours

Placebo - All Patients on Mechanical Ventilation for ≤48 Hours

Placebo - US Patients on Mechanical Ventilation for ≤48 Hours

Placebo - All Patients on Mechanical Ventilation for >48 Hours

Placebo - US Patients on Mechanical Ventilation for >48 Hours

SEALS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: L-citrullineExperimental Treatment1 Intervention

L-citrulline with a dose of 15 g/day will be administered in powder form that is mixed with water and taken orally, continuously and daily for at least 7 weeks. Dispensed at Visits 0a/1. Washout period of 4 to 6 weeks and then enter crossover phase of an additional 7 weeks. Drug will be dispensed at Visit 4.

Group II: Matching PlaceboPlacebo Group1 Intervention

Administered in powder form that is mixed with water and taken orally, continuously, and daily for at least 7 weeks. Dispensed at Visits 0a/. Washout period of 4 to 6 weeks and then enter crossover phase of an additional 7 weeks. Drug will be dispensed at Visit 4.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

L-citrulline

2010

Completed Phase 3

~530

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Jewish HealthOTHER

140 Previous Clinical Trials

316,161 Total Patients Enrolled

23 Trials studying Asthma

17,709 Patients Enrolled for Asthma

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,451 Total Patients Enrolled

20 Trials studying Asthma

2,910 Patients Enrolled for Asthma

United States Department of DefenseFED

865 Previous Clinical Trials

327,624 Total Patients Enrolled

Media Library

L-citrulline Clinical Trial Eligibility Overview. Trial Name: NCT05259904 — Phase 2

Asthma Research Study Groups: L-citrulline, Matching Placebo

Asthma Clinical Trial 2023: L-citrulline Highlights & Side Effects. Trial Name: NCT05259904 — Phase 2

L-citrulline 2023 Treatment Timeline for Medical Study. Trial Name: NCT05259904 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is L-citrulline consumption associated with any adverse health risks?

"Our team at Power rated L-citrulline's safety a 2 because there is data demonstrating its security, but no existing evidence of efficacy stemming from this Phase 2 trial."

Answered by AI

Are additional participants being welcomed for this research endeavor?

"As listed on clinicaltrials.gov, this particular trial is not actively recruiting patients. It was first published back in April of 2024 and the last update to the trial occurred on June 23rd 2022. At present, there are no openings for participants; however, 318 other trials are seeking enrolment at this time."

Answered by AI

Am I able to participate in this medical experiment?

"This clinical trial is search of 75 qualified individuals, aged between 18 and 70, who suffer from asthma. The criteria for enrolment necessitates that participants have consented to the study in writing; are men or women both within the age range specified; evidence of deployment-related asthma (DRA) or other respiratory symptoms post 2001 military service; an observable increase in FEV1 after bronchodilator administration accompanied by hyper responsiveness as indicated via methacholine challenge test results below 16 mg/mL; a smoking history not exceeding 15 pack years and no tobacco use over 3 months prior to enrollment ; suboptimal baseline assessment scores according"

Answered by AI