Reducing Breathlessness With Dronabinol in COPD Patients

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Dronabinol 2.5mg Capsule
  Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
• Препарат Placebo
  Dronabinol-matched placebo capsule containing no active substance.

Первичные конечные точки

• Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Assessed daily in the baseline period and through both treatment periods. Up to 70 days]

Вторичные конечные точки (12)

• Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Дания · 1 центр

• Vejle Hospital - A part of Lillebaelt Hospital — Vejle

Публикации

• Wolsing SK, Hilberg O, Lokke A, Farver-Vestergaard I, Andersen CU, Hansen KK. Reducing severe breathlessness with dronabinol in the group of patients with severe and very severe chronic obstructive pulmonary disease (BONG): a randomised, double-blinded, placebo-controlled, crossover study in an outpatient clinic in Denmark - a study protocol. BMJ Open. 2026 Feb 16;16(2):e104957. doi: 10.1136/bmjop PMID 41698715

Идентификаторы

NCT: NCT06473701 · 2024-513593-22-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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