Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00830102
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2009-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
Sponsor:
SkyePharma AG
Organization:
Study Overview
Official Title:
A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: