Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
Study NCT ID:
NCT03795350
Status:
TERMINATED
Last Update Posted:
2022-05-06
First Post:
2018-12-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients
Sponsor:
Chiesi Farmaceutici S.p.A.
Organization:
Study Overview
Official Title:
Open Label, Uncontrolled, Non-randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mTc Radiolabelled TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
In light of the cessation of non-essential clinical activities at CPU due to the COVID-19 pandemic, the sponsor has determined to terminate the study early.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STORM
Brief Summary:
The purpose of this study is to investigate the lung deposition and distribution pattern of TRIMBOW using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled TRIMBOW administered via pMDI in healthy volunteers, asthmatic and COPD patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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 |
|---|---|---|---|---|
| 2017-005030-29 | EUDRACT_NUMBER | None | View |