Reducción de la dificultad para respirar con dronabinol en pacientes con EPOC (BONG)
BONG: Reducción de la disnea grave con dronabinol en el grupo de pacientes con enfermedad pulmonar obstructiva crónica grave y muy grave: un estudio cruzado, aleatorizado, doble ciego y controlado con placebo
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).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Region Syddanmark
-
Vejle, Region Syddanmark, Dinamarca, 7100
- Vejle Hospital - A part of Lillebaelt Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Refractory dyspnea despite optimal treatment
- COPD (GOLD 3,4)
- Breathlessness corresponding to mMRC score ≥ 3
- Informed written consent
- Age ≥ 18 years
- Cognitive relevant, of legal age
- Understands and speaks Danish
- For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial
- For fertile and sexually active subjects: use of safe contraception during medication intake and 4 weeks after: intrauterine device (IUD) or hormonal contraception (oral contraceptive pill, implant, transdermal patch, vaginal ring or depot injection).
Exclusion Criteria:
- Ongoing infection or exacerbation of COPD within the last month (30 days)
- Regular treatment with THC or CBD within 1 month (30 days)
- Life expectancy less than 3 months (90 days)
- Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19
- History of or current evidence of significant medical or psychiatric disorder that is considered by the investigator to put the subject at greater risk of experiencing an adverse event
- Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Dronabinol 20 mg, then placebo
In this arm, the study subject will first receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. |
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
Otros nombres:
Dronabinol-matched placebo capsule containing no active substance. |
|
Comparador de placebos: Placebo, then dronabinol 20 mg
In this arm, the study subject will first receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. |
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
Otros nombres:
Dronabinol-matched placebo capsule containing no active substance. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
Periodo de tiempo: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
|
Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo
Periodo de tiempo: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
|
Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period
Periodo de tiempo: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
|
Correlation between breathlessness interference of daily activities rated on a numeric rating scale in relation to amount of THC blood level of the active treatment period
Periodo de tiempo: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Assesses different dimensions of COPD. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in COPD Assessment Test questionnaire score between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Assesses the severity of physical COPD symptoms. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in Chronic Respiratory Disease Questionnaire score between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A HRQL tool which incorporates patient perceptions of both physical and emotional health. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Assess anxiety and depression symptoms in medical patients. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in Medical Research Council Dyspnea Scale questionnaire score between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A simple and valid method of categorizing patients with COPD in terms of their disability that could be used to complement FEV1 in the classification of COPD severity. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in Epworth Sleepiness Scale questionnaire score between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Assesses person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in the spirometry parameter forced expiratory volume in 1. second (FEV1) between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
The FEV1 indicates the lung tissue's ability to release air during the first second of exhalation. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in the spirometry parameter forced vital capacity (FVC) between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
The FVC indicates the lung tissue's ability to release air during the entire exhalation. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in the spirometry parameter FEV1/FVC (ratio), between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Can indicate an obstructive pattern in the exhalation which are used in the diagnosis of COPD. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in six-minute walk test(6MWT) between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
6 minutes walking test measures breathlessness and performance ability. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference Borg dyspnea score conducted in relation to 6MWT between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A numeric scale from 0 (no breathlessness) to 10 (extremely strong breathlessness) but not limited to 10 if subjects feel breathlessness above 10 |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in cortisol level in the hair samples between active treatment and placebo period
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Measurement of stress through cortisol levels in the hair. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
For several days in each treatment period we continuously measure blood oxygen saturation, electrodermal activity, pulse rate, sleep recording, temperature, respiratory rate, and activity counter. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in stand-to-sit-test between active treatment and placebo
Periodo de tiempo: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A measurement for physical capability until breathlessness. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ole Hilberg, Prof., MD, Medical Department, Vejle Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Trastornos de la respiración
- Enfermedades Pulmonares Obstructivas
- Trastornos relacionados con sustancias
- Trastornos inducidos químicamente
- Signos y Síntomas Respiratorios
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedad Pulmonar Obstructiva Crónica
- Abuso de marihuana
- Disnea
- Químicos orgánicos
- Hidrocarburos
- Terpenos
- Cannabinoides
- Dronabinol
Otros números de identificación del estudio
- 2024-513593-22-00
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
It is the plan to share SAP when this is finalized. It is undecided whether CSR and analytic code will be shared on a platform or available on reasonable request.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .