Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-06 @ 12:27 AM
Study NCT ID:
NCT03108534
Status:
COMPLETED
Last Update Posted:
2018-10-04
First Post:
2017-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.
Sponsor:
Chiesi Farmaceutici S.p.A.
Organization:
Study Overview
Official Title:
A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-way Crossover Clinical Study, Comparing the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 100/6 µg NEXThaler® Versus CHF1535 100/6 µg pMDI in Asthmatic Patients.
Status:
COMPLETED
Status Verified Date:
2018-10
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:
The clinical trial is designed to evaluate the non-inferiority of CHF1535 100/6 µg NEXThaler versus CHF1535 100/6 µg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| 2016-003672-47 | EUDRACT_NUMBER | None | View |