Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-02 @ 10:04 PM
Study NCT ID:
NCT00734318
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2008-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma
Sponsor:
Mundipharma Research Limited
Organization:
Study Overview
Official Title:
A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With 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:
The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.
Detailed Description:
This is a study involving a 2 week run-in phase followed by an 8 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the four treatment groups and will receive either high dose FlutiForm® and Foradil® plus Flixotide® placebo or low dose FlutiForm® plus Foradil® and Flixotide® placebo or Foradil® plus Flixotide® and FlutiForm® placebo or Flixotide® and FlutiForm® plus Foradil® placebo. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-001633-34 | None | None | View |