COPDPhase 3BONGNCT06473701
Reducing Breathlessness With Dronabinol in COPD Patients
A Phase 3 study testing Dronabinol 2.5mg Capsule in people with COPD and Breathlessness, run by Vejle Hospital at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Breathlessness, Cannabis
- What is being tested?
- Dronabinol 2.5mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Feb 2025to 21 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Vejle Hospital - A part of Lillebaelt Hospital
Vejle, Region Syddanmark, 7100
About this study
Official title: 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
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).
Read the detailed description
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.
- Conditions
- COPD, Breathlessness, Cannabis
- Being tested
- Dronabinol 2.5mg Capsule, Placebo
- Keywords
- Randomized, Controlled, Double-blind, Crossover trial, Cannabis-based medicine, Cannabis, COPD, Breathlessness
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol 2.5mg CapsuleDrug
Also called Delta9-tetrahydrocannabinol
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
PlaceboDrug
Dronabinol-matched placebo capsule containing no active substance.
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol 20 mg, then placebo | Experimental | 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. Receives: Drug: Dronabinol 2.5mg Capsule; Drug: Placebo |
| Placebo, then dronabinol 20 mg | Placebo comparator | 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. Receives: Drug: Dronabinol 2.5mg Capsule; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness
Measured: 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
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities
Measured: 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
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness
Measured: 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
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities
Measured: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
Secondary outcomes (12)
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
Assesses different dimensions of COPD.
Measured: 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
Assesses the severity of physical COPD symptoms.
Measured: 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
A HRQL tool which incorporates patient perceptions of both physical and emotional health.
Measured: 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
Assess anxiety and depression symptoms in medical patients.
Measured: 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
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.
Measured: 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
Assesses person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Measured: 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
The FEV1 indicates the lung tissue's ability to release air during the first second of exhalation.
Measured: 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
The FVC indicates the lung tissue's ability to release air during the entire exhalation.
Measured: 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
Can indicate an obstructive pattern in the exhalation which are used in the diagnosis of COPD.
Measured: 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
6 minutes walking test measures breathlessness and performance ability.
Measured: 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
A numeric scale from 0 (no breathlessness) to 10 (extremely strong breathlessness) but not limited to 10 if subjects feel breathlessness above 10
Measured: 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
Measurement of stress through cortisol levels in the hair.
Measured: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start26 Feb 2025
- Primary completion21 Sep 2026
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, controlled, double-blind, crossover trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Odense Patient Data Explorative Network, University of Southern Denmark, University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Ole Hilberg, Prof., MD, Principal investigator, Medical Department, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473701
- Sponsor's protocol ID
- 2024-513593-22-00
- Acronym
- BONG
- Status last verified
- Oct 2026
- First submitted
- 22 May 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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/bmjopen-2025-104957.
PubMed 41698715
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06473701
- Acronym / sponsor ID
- BONG / 2024-513593-22-00
- Conditions
- COPD, Breathlessness, Cannabis
- Keywords
- Randomized, Controlled, Double-blind, Crossover trial, Cannabis-based medicine, Cannabis, COPD, Breathlessness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Odense Patient Data Explorative Network, University of Southern Denmark, University of Aarhus
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 21 Sep 2026 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, controlled, double-blind, crossover trial
| Arm | Type | Receives |
|---|---|---|
| Dronabinol 20 mg, then placebo | Experimental | Drug: Dronabinol 2.5mg Capsule, Drug: PlaceboIn 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. |
| Placebo, then dronabinol 20 mg | Placebo comparator | Drug: Dronabinol 2.5mg Capsule, Drug: PlaceboIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Refractory dyspnea despite optimal treatment
- COPD (GOLD 3,4)
- Breathlessness corresponding to mMRC score ≥ 3
- Informed written consent
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol 2.5mg CapsuleAlso: Delta9-tetrahydrocannabinolDronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose. | Drug | Dronabinol 20 mg, then placebo, Placebo, then dronabinol 20 mg |
| PlaceboDronabinol-matched placebo capsule containing no active substance. | Drug | Dronabinol 20 mg, then placebo, Placebo, then dronabinol 20 mg |
Primary outcome
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
Time frame: 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
Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo
Time frame: 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
Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period
Time frame: 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
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
Time frame: 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
12 secondary outcomes
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 41698715Wolsing 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/bmjopen-2025-104957.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Hilberg, Prof., MD principal investigator
Medical Department, Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dronabinol 2.5mg Capsule in people with COPD and Breathlessness, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo (time frame: Assessed daily in the baseline period and through both treatment periods. Up to 70 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.