Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT02148120
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler
Sponsor:
Chiesi Farmaceutici S.p.A.
Organization:
Study Overview
Official Title:
A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthmatic Patients.
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:
None
Brief Summary:
The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.
Detailed Description:
None
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?: