Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01650441
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2012-06-29
Brief Title:
Study to Assess the Effect of the NEXThaler Device DPI - Dry Powder Inhaler on the Central and Peripheral Airway Dimensions in Asthmatic Patients
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
OPEN-LABEL PROSPECTIVE EXPLORATORY STUDY TO ASSESS THE EFFECTS OF FORMOTEROL AND BECLOMETASONE DIPROPIONATE COMBINATION THERAPY USING A DPI DEVICE ON CENTRAL AND PERIPHERAL AIRWAY DIMENSIONS IN ASTHMATIC PATIENTS
Status:
COMPLETED
Status Verified Date:
2015-05
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 objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate in a dry powder inhaler NEXThaler on central and peripheral airway dimensions in asthmatic patients Therefore Computational Fluid Dynamics CFD will be used Further more the effect of this combination therapy on lung function spirometry resistance and diffusion the Asthma Control Test ACT and the Asthma Control Questionnaire ACQ will be assessed and the safety will be evaluated
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 |
|---|---|---|---|
| 2011-003249-16 | EUDRACT_NUMBER | None | None |