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Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2002 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00029731
First received: January 21, 2002
Last updated: June 23, 2005
Last verified: January 2002
History of Changes
  Purpose

This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS.


Condition Intervention Phase
Anemia, Sickle Cell
Pneumonia
 Drug: Arginine hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 30
Study Start Date: August 2001
Estimated Study Completion Date: July 2004
Detailed Description:

Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome. ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD. Multiple factors are involved in the severity of acute pulmonary injury in SCD. Nitric oxide has a multitude of related functions, many of which could impact favorably on ACS in SCD. Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase. Nitric oxide and its precursor, arginine, are known to be low in SCD patients with ACS, suggesting that therapies, such as arginine, aimed at increasing nitric oxide production will improve the clinical course of ACS. Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized. The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia)

Acute chest syndrome with the following:

  • New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following:
  • Fever
  • Cough, tachypnea, retractions, rales, or wheezing
  • Chest pain

Exclusion criteria:

  • Inability to take or tolerate oral medications
  • Hepatic dysfunction (SGPT greater than 2 times normal)
  • Renal dysfunction (creatinine greater than 2 times normal)
  • Mental status or neurological changes
  • Allergy to arginine
  • History of priapism
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029731

Locations
United States, California
Children's Hospital Oakland Recruiting
Oakland, California, United States, 94609
Contact: Lori A. Styles, M.D.     510-428-3553     lstyles@mail.cho.org    
Principal Investigator: Lori A. Styles, M.D.            
Sponsors and Collaborators
FDA Office of Orphan Products Development
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00029731     History of Changes
Other Study ID Numbers: FD-R-1978-01, FD-R-001978-01
Study First Received: January 21, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
Nitric Oxide
Administration, Oral

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia
Pneumonia
Acute Chest Syndrome
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Hemoglobinopathies
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders

ClinicalTrials.gov processed this record on May 16, 2013