Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 11:27 PM
Study NCT ID:
NCT01651650
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2012-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler® Dry Powder Inhaler (DPI) Device
Sponsor:
Chiesi Farmaceutici S.p.A.
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-03
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:
NEXThalerPIF
Brief Summary:
Phase IIa, single-centre, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler® device in adult asthmatic patients with varying degrees of disease control.
Detailed Description:
The primary objective of this study is to assess the inspiratory flow profile through the NEXThaler® device in adult asthmatics with varying degrees of disease control.
The study plan foresees one visit at clinic. At Visit 1, after the signature of the informed consent form, the inclusion/exclusion criteria will be checked and the lung function parameters will be evaluated. If the subjects meet the inclusion/exclusion criteria, they will be instructed to use the NEXThaler®. The patients will subsequently inhale through the device and the inspiration profile will be measured.
A total of 40 asthmatic adults (≥18 years), 20 with controlled stable disease and 20 with partly controlled or uncontrolled disease according to GINA guidelines (2011), will be enrolled.
The study plan foresees one visit at clinic. At Visit 1, after the signature of the informed consent form, the inclusion/exclusion criteria will be checked and the lung function parameters will be evaluated. If the subjects meet the inclusion/exclusion criteria, they will be instructed to use the NEXThaler®. The patients will subsequently inhale through the device and the inspiration profile will be measured.
A total of 40 asthmatic adults (≥18 years), 20 with controlled stable disease and 20 with partly controlled or uncontrolled disease according to GINA guidelines (2011), will be enrolled.
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 |
|---|---|---|---|---|
| 2012-000039-22 | EUDRACT_NUMBER | None | View |