BONG: Breathlessness and alternatives to Opioid treatment in Non-malign Groups of severe lung disease

BONG: Breathlessness and alternatives to Opioid treatment in Non-malign Groups of severe lung disease - Dronabinol in COPD patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-004238-20-DK

Enrollment

Registered

2023-01-17

Start date

2024-02-06

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD MedDRA version: 21.1 Level: PT Classification code 10075530 Term: Medical cannabis therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Dronabinol kapsel 2,5 mg Pharmaceutical Form: Capsule, soft INN or Proposed INN: Dronabinol CAS Number: 1972-08-3 Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Severe COPD, GOLD C,D, Age >18 years, informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Infection, psychiatric disorder, maternaty

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of Dronabinol in COPD;Secondary Objective: Not applicable;Primary end point(s): Breathlessness on VAS scale;Timepoint(s) of evaluation of this end point: 12 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): CRQ, CAT, MRC, HADS;Timepoint(s) of evaluation of this end point: 12 weeks	—

Countries

Denmark

Contacts

Public ContactClinical Trial Information

Vejle Hospital

medicinsk.amb.lungemedicin@rsyd.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026