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Reduzindo a falta de ar com dronabinol em pacientes com DPOC (BONG)

2 de outubro de 2026 atualizado por: Vejle Hospital

BONG: Reduzindo a falta de ar grave com dronabinol no grupo de pacientes com doença pulmonar obstrutiva crônica grave e muito grave - um estudo cruzado randomizado, duplo-cego, controlado por 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).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

30

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Dinamarca
    • Region Syddanmark
      • Vejle, Region Syddanmark, Dinamarca, 7100
        • Vejle Hospital - A part of Lillebaelt Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: Dronabinol 2.5mg Capsule

Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.

Outros nomes:
  • Delta9-tetrahidrocanabinol
Medicamento: Placebo

Dronabinol-matched placebo capsule containing no active substance.
Comparador de Placebo: 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.
Medicamento: Dronabinol 2.5mg Capsule

Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.

Outros nomes:
  • Delta9-tetrahidrocanabinol
Medicamento: Placebo

Dronabinol-matched placebo capsule containing no active substance.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Vejle Hospital

Colaboradores

University of Aarhus
University of Southern Denmark
Region of Southern Denmark
Odense Patient Data Explorative Network

Investigadores

  • Investigador principal: Ole Hilberg, Prof., MD, Medical Department, Vejle Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

26 de fevereiro de 2025

Conclusão Primária (Real)

21 de setembro de 2026

Conclusão do estudo (Real)

21 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

22 de maio de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de junho de 2024

Primeira postagem (Real)

25 de junho de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2024-513593-22-00

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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