Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03870841
Status:
TERMINATED
Last Update Posted:
2021-07-16
First Post:
2018-10-24
Brief Title:
The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
Sponsor:
Pulmocide Ltd
Organization:
Pulmocide Ltd
Study Overview
Official Title:
An Open-label Study to Assess the Safety Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis CF Patients With Persistent Pulmonary Aspergillus Fumigatus Infection
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study is being terminated early as a result of the coronavirus COVID-19 outbreak
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study tests the effects of an experimental drug PC945 in people with cystic fibrosis whose lungs are infected by the fungus Aspergillus fumigatus
PC945 may be useful in treating patients infected with Aspergillus fumigatus as unlike the usual treatments it is inhaled into the lung and has been designed to stay there and treat the infection Participants will continue to be treated with their usual cystic fibrosis treatment and will also receive PC945 The amount of fungus in the patients phlegm will be measured over the course of the study The study will take place at multiple sites in UK and will include approximately 18 participants The maximum study duration will be about 16 weeks
PC945 may be useful in treating patients infected with Aspergillus fumigatus as unlike the usual treatments it is inhaled into the lung and has been designed to stay there and treat the infection Participants will continue to be treated with their usual cystic fibrosis treatment and will also receive PC945 The amount of fungus in the patients phlegm will be measured over the course of the study The study will take place at multiple sites in UK and will include approximately 18 participants The maximum study duration will be about 16 weeks
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-000243-87 | EUDRACT_NUMBER | None | None |