Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369993
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2006-08-28
Brief Title:
Spacer Comparison In Adult Asthmatics
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomised Open Label Five-way Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol From SERETIDEADVAIR 250HFA MDI Alone and With AeroChamber-Max Spacer and VOLUMATIC Both in Their Washed and Unwashed States in Adult Subjects With Mild or Intermittent Asthma
Status:
COMPLETED
Status Verified Date:
2016-10
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:
Spacers are used by people with respiratory diseases who have problems using MDIs metered dose inhalers This study used fluticasone propionatesalmeterol to look at the pharmacokinetic profiles produced by different spacers in their washed and un-washed states
Detailed Description:
A randomised open label five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from SERETIDEADVAIR 250 HFA MDI without spacer and with AeroChamber-Max spacer and VOLUMATIC both in their washed and unwashed states in adult subjects with mild or intermittent asthma
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