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Réduire l'essoufflement avec le dronabinol chez les patients atteints de BPCO (BONG)

2 octobre 2026 mis à jour par: Vejle Hospital

BONG : Réduire l'essoufflement sévère avec le dronabinol dans le groupe de patients atteints de maladie pulmonaire obstructive chronique sévère et très sévère - Une étude croisée randomisée, en double aveugle, contrôlée par 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

30

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Dronabinol 2.5mg Capsule

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

Autres noms:
  • Delta9-tétrahydrocannabinol
Médicament: Placebo

Dronabinol-matched placebo capsule containing no active substance.
Comparateur 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.
Médicament: Dronabinol 2.5mg Capsule

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

Autres noms:
  • Delta9-tétrahydrocannabinol
Médicament: Placebo

Dronabinol-matched placebo capsule containing no active substance.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Vejle Hospital

Collaborateurs

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

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 février 2025

Achèvement primaire (Réel)

21 septembre 2026

Achèvement de l'étude (Réel)

21 septembre 2026

Dates d'inscription aux études

Première soumission

22 mai 2024

Première soumission répondant aux critères de contrôle qualité

18 juin 2024

Première publication (Réel)

25 juin 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2024-513593-22-00

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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