Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00004705|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis.
II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: amiloride Drug: uridine||Not Applicable|
PROTOCOL OUTLINE: Patients may be treated on any of three different regimens. Patients may be treated on more than one regimen, if they meet the eligibility requirements.
Patients on regimen A are adults and receive uridine triphosphate (UTP) by inhalation, followed immediately by bronchoscopy.
Patients on regimen B are children, aged 4 to 10 years. Patients receive up to 4 graded doses of UTP by inhalation on day 1. On day 2, patients receive a single dose of UTP. Patients receive amiloride followed by UTP by inhalation on day 3.
Patients on regimen C are children, aged 4 to 18 years. Patients inhale a radiolabelled (technetium 99m) monodisperse iron oxide aerosol. Radiation deposited in the patient's lungs is monitored. Patients are randomized to receive one of 4 different aerosols (vehicle; UTP; amiloride; or UTP plus amiloride), which is inhaled for 20 minutes. Patients are followed 24 hours after aerosol exposure.
Regimen D is a dose escalation study in which patients are aged 9 to 40 years. Patients receive either the vehicle or UTP by inhalation 3 times daily for 3 days. Cohorts of 4 patients each are entered at each dose level.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||September 1996|
|Study Completion Date :||January 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004705
|Study Chair:||Michael R. Knowles||University of North Carolina|