Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004705
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Study of Uridine Triphosphate UTP as an Aerosol Spray for Cystic Fibrosis
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
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:
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
II Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis
Detailed Description:
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-FDR001008 | None | None | None |