Ignite Creation Date:
2024-05-06 @ 1:22 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01795664
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2013-01-31
Brief Title:
Compare the Effects of Seretide Evohaler and a Generic SalmeterolFluticasone Hydrofluoroalkane HFA Pressurized Metered-dose Inhaler pMDI on Functional Respiratory Imaging Parameters in Asthmatic Patients
Sponsor:
FLUIDDA nv
Organization:
FLUIDDA nv
Study Overview
Official Title:
A Double Blind Double Dummy Randomized Two Way Cross-over Study to Compare the Effects of Seretide Evohaler Supplied by Allen Hanburys UK and a Generic SalmeterolFluticasone HFA pMDI Manufactured by Cipla Ltd India on Functional Respiratory Imaging Parameters in Asthmatic Patients
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This study will be conducted as a randomized double blind double dummy two period crossover study in stable asthma patients A total of 16 stable asthma patients treated in accordance with the Global Initiative for Asthma GINA guidelines will be included
Objectives
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging FRI parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic CFD
The secondary objectives are to assess the effect of both the study drugs on lung function spirometry and body plethysmography on exercise capacity 6 Minutes Walking Test 6MWT and on dyspnea Borg Category C Ratio R 10 Scale and Visual Analog Scale VAS dyspnea Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events AEs throughout the study
Objectives
The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging FRI parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic CFD
The secondary objectives are to assess the effect of both the study drugs on lung function spirometry and body plethysmography on exercise capacity 6 Minutes Walking Test 6MWT and on dyspnea Borg Category C Ratio R 10 Scale and Visual Analog Scale VAS dyspnea Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events AEs throughout the study
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| E-RES1212-Q13 | OTHER | Cipla Ltd India | None |
| 2012-005789-36 | EUDRACT_NUMBER | None | None |