Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-04 @ 5:31 PM
Study NCT ID:
NCT00563056
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2007-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
Sponsor:
Mundipharma Research Limited
Organization:
Study Overview
Official Title:
Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.
Detailed Description:
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive Flutiform® or Flixotiole® and Foradil® as individual componements. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-001634-13 | None | None | View |