Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473701
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-22
Brief Title:
Reducing Breathlessness With Dronabinol in COPD Patients
Sponsor:
Vejle Hospital
Organization:
Vejle Hospital
Study Overview
Official Title:
BONG Reducing Severe Breathlessness With Dronabinol in the Severe and Very Severe Chronic Obstructive Pulmonary Disease Patient Group - A Randomized Double-Blind Placebo-Controlled Crossover Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
BONG
Brief Summary:
This clinical trial examines whether Dronabinol which contains the synthetic psychoactive compound tetrahydrocannabinol THC can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease COPD
Detailed Description:
This study is a randomized controlled double-blind crossover trial evaluating the effectiveness of the pharmaceutical drug Dronabinol in patients with severe and very severe COPD
The researchers will compare the effects of Dronabinol with a placebo an identical-looking substance that contains no active drug to determine if Dronabinol reduces breathlessness in COPD patients
After enrollment study subjects will undergo four weeks of treatment with both Dronabinol and the placebo in a blinded and randomized sequence There is a two-week washout period between treatments During these treatment phases subjects will complete questionnaires about their daily experiences of breathlessness and wear a watch that records various health parameters
The study includes eight visits the initial enrollment and follow-up checks every two weeks At these visits subjects undergo tests for lung function and walking distance and complete health status questionnaires Additionally blood samples for THC levels and hair samples for cortisol analysis are collected
The researchers will compare the effects of Dronabinol with a placebo an identical-looking substance that contains no active drug to determine if Dronabinol reduces breathlessness in COPD patients
After enrollment study subjects will undergo four weeks of treatment with both Dronabinol and the placebo in a blinded and randomized sequence There is a two-week washout period between treatments During these treatment phases subjects will complete questionnaires about their daily experiences of breathlessness and wear a watch that records various health parameters
The study includes eight visits the initial enrollment and follow-up checks every two weeks At these visits subjects undergo tests for lung function and walking distance and complete health status questionnaires Additionally blood samples for THC levels and hair samples for cortisol analysis are collected
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?:
False
Is an FDA AA801 Violation?:
None