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Reduzierung der Atemnot mit Dronabinol bei COPD-Patienten (BONG)

2. Oktober 2026 aktualisiert von: Vejle Hospital

BONG: Reduzierung schwerer Atemnot mit Dronabinol in der Patientengruppe mit schwerer und sehr schwerer chronisch obstruktiver Lungenerkrankung – eine randomisierte, doppelblinde, placebokontrollierte Crossover-Studie

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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

30

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: Dronabinol 2.5mg Capsule

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

Andere Namen:
  • Delta9-Tetrahydrocannabinol
Arzneimittel: Placebo

Dronabinol-matched placebo capsule containing no active substance.
Placebo-Komparator: 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.
Arzneimittel: Dronabinol 2.5mg Capsule

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

Andere Namen:
  • Delta9-Tetrahydrocannabinol
Arzneimittel: Placebo

Dronabinol-matched placebo capsule containing no active substance.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Vejle Hospital

Mitarbeiter

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

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Februar 2025

Primärer Abschluss (Tatsächlich)

21. September 2026

Studienabschluss (Tatsächlich)

21. September 2026

Studienanmeldedaten

Zuerst eingereicht

22. Mai 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2024

Zuerst gepostet (Tatsächlich)

25. Juni 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2024-513593-22-00

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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