Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056147
Status:
COMPLETED
Last Update Posted:
2015-01-29
First Post:
2003-03-06
Brief Title:
Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Multi-Center Double-Blind Randomized Placebo-Controlled 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis CF lung disease Study drug will be administered through a nebulizer a device that delivers medication as a mist by breathing it in
Detailed Description:
The purpose of this study is to
assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease
explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer
identify doses that will be studied in subsequent trials
assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease
explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer
identify doses that will be studied in subsequent trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None