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
|First Submitted Date ICMJE||February 24, 2000|
|First Posted Date ICMJE||February 25, 2000|
|Last Update Posted Date||March 25, 2015|
|Study Start Date ICMJE||September 1996|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis|
|Official Title ICMJE||Not Provided|
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.
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 ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Cystic Fibrosis|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date ICMJE||January 1999|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Diagnosis of mild to moderate cystic fibrosis Small production of daily airway secretions Stable pulmonary course --Prior/Concurrent Therapy-- Radiotherapy: No radiation within 12 months to cause patient to exceed annual limits Other: No chronic medication for reactive airways disease At least 12 hours since inhaled beta-adrenergic agonists At least 24 hours since systemic theophylline --Patient Characteristics-- FEV1 greater than 50% predicted Other: Not pregnant Must perform reproducible spirometry
|Ages ICMJE||4 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT00004705|
|Other Study ID Numbers ICMJE||199/13446
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||FDA Office of Orphan Products Development|
|Collaborators ICMJE||University of North Carolina|
|PRS Account||FDA Office of Orphan Products Development|
|Verification Date||March 1999|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP