BONG: Reducing severe Breathlessness with Dronabinol in the severe and very severe chronic obstructive pulmonary disease patient group

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Lillebaelt Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

31 Jan 2025 → ongoing

Decision date (initial)

2024-05-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-513593-22-00

EudraCT number

2022-004238-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

This clinical trial study is a randomized, controlled, double blinded, crossover trial testing the pharmaceutical drug Dronabinol for patients with severe and very severe chronic obstrutive pulmonary disease (COPD). The study will investigate whether Dronabinol, containing the psychoactive compound Δ9-tetrahydrocannabinol from synthethic produced cannabis, relieves breathlessness in patients with COPD.

Conditions and MedDRA coding

Chronic obstructive pulmonary disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Refractory dyspnea despite optimal treatment
2. COPD (GOLD 3,4)
3. Breathlessness corresponding to mMRC score ≥ 3
4. Informed written consent
5. Age ≥ 18 years
6. Cognitive relevant, of legal age
7. Understands and speaks Danish
8. For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial
9. 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 6

1. Ongoing infection or exacerbation of COPD within the last month (30 days)
2. Regular treatment with THC or CBD within 1 month (30 days)
3. Life expectancy less than 3 months (90 days)
4. Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19
5. 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
6. Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Comparison of Numeric Rating Scale (NRS) score of discomfort of daily breathlessness and daily interference of daily activities in relation to active treatment vs. placebo.
2. Comparison of NRS score of discomfort of daily breathlessness and daily interference of daily activities in relation to amount of THC level from the blood sample of the active treatment.

Secondary endpoints 10

1. Difference in MDP (multidimensional dyspnea profile) in relation to active treatment vs. placebo
2. Difference in CAT (COPD assessment test) in relation to active treatment vs. placebo
3. Difference in CRQ (chronic respiratory disease questionnaire) in relation to active treatment vs. placebo
4. Difference in HADS (Hospital Anxiety and Depression Scale) in relation to active treatment vs. placebo
5. Difference in MRC score (Medical Research Council) in relation to active treatment vs. placebo
6. Difference in ESS (Epworth sleepiness score) in relation to active treatment vs. placebo
7. Difference in Spirometry (FEV1, FVC, FEV1/FVC (ratio)) in relation to active treatment vs. placebo
8. Difference in 6MWT (Six-minute walk test including BORG score) in relation to active treatment vs. placebo
9. Difference in hair cortisol level in relation to active treatment vs. placebo
10. Difference in parameters from Empatica Embrace watch (such as continuous measurement of SpO2 (blood oxygen saturation), EDA (electrodermal activity), P (pulse rate), sleep recording, temperature and respiratory rate, activity counter) in relation to active treatment vs. placebo

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Lillebaelt Hospital

Sponsor organisation

Lillebaelt Hospital

Address

Beriderbakken 4

City

Vejle

Postcode

7100

Country

Denmark

Scientific contact point

Organisation

Lillebaelt Hospital

Contact name

Coordinating investigator

Public contact point

Organisation

Lillebaelt Hospital

Contact name

Coordinating investigator

Third parties 3

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications