Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360094
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-04-08
Brief Title:
A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase IIaIIb Randomised Double Blind Placebo-controlled Parallel-group Dose-finding Study to Examine the Efficacy and Safety of BI 1839100 Administered Orally Over a 12-week Treatment Period in Patients With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis With Clinically Meaningful Cough
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Adults 40 years of age and older with idiopathic pulmonary fibrosis IPF or 18 years and older with progressive pulmonary fibrosis PPF can participate in this study Only people who have a chronic cough can take part The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF
Participants who have IPF are put into 4 groups by chance Participants in 3 groups get different doses of BI 1839100 Participants in 1 group get placebo Placebo looks like BI 1839100 but does not contain any medicine Participants take the treatment for 3 months After 1 month of treatment participants who take the highest dose will have coughing measured to find out if the medicine works If it does not work the study may be stopped Participants who have IPF are in the study for slightly longer than 4 months During this time they visit the study site 7 times This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF
During the study coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study Participants fill in questionnaires about their coughing Doctors also perform breathing tests that measure how well the lungs are working at the site visits Researchers compare the results between participants who take BI 1839100 and placebo The doctors also regularly check participants health and take note of any unwanted effects
Participants who have IPF are put into 4 groups by chance Participants in 3 groups get different doses of BI 1839100 Participants in 1 group get placebo Placebo looks like BI 1839100 but does not contain any medicine Participants take the treatment for 3 months After 1 month of treatment participants who take the highest dose will have coughing measured to find out if the medicine works If it does not work the study may be stopped Participants who have IPF are in the study for slightly longer than 4 months During this time they visit the study site 7 times This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF
During the study coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study Participants fill in questionnaires about their coughing Doctors also perform breathing tests that measure how well the lungs are working at the site visits Researchers compare the results between participants who take BI 1839100 and placebo The doctors also regularly check participants health and take note of any unwanted effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2023-510249-79-00 | REGISTRY | None | None |
| U1111-1301-1311 | REGISTRY | WHO Registry ICTRP | None |