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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513593-22-00
Enrollment
30
Registered
2024-05-14
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-06-20

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

Conditions

Chronic obstructive pulmonary disease

Brief summary

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., 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.

Detailed description

Difference in MDP (multidimensional dyspnea profile) in relation to active treatment vs. placebo, Difference in CAT (COPD assessment test) in relation to active treatment vs. placebo, Difference in CRQ (chronic respiratory disease questionnaire) in relation to active treatment vs. placebo, Difference in HADS (Hospital Anxiety and Depression Scale) in relation to active treatment vs. placebo, Difference in MRC score (Medical Research Council) in relation to active treatment vs. placebo, Difference in ESS (Epworth sleepiness score) in relation to active treatment vs. placebo, Difference in Spirometry (FEV1, FVC, FEV1/FVC (ratio)) in relation to active treatment vs. placebo, Difference in 6MWT (Six-minute walk test including BORG score) in relation to active treatment vs. placebo, Difference in hair cortisol level in relation to active treatment vs. placebo, 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

Interventions

DRUGDronabinol
DRUGPLACEBO

Sponsors

Lillebaelt Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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., 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

MeasureTime frame
Difference in MDP (multidimensional dyspnea profile) in relation to active treatment vs. placebo, Difference in CAT (COPD assessment test) in relation to active treatment vs. placebo, Difference in CRQ (chronic respiratory disease questionnaire) in relation to active treatment vs. placebo, Difference in HADS (Hospital Anxiety and Depression Scale) in relation to active treatment vs. placebo, Difference in MRC score (Medical Research Council) in relation to active treatment vs. placebo, Difference in ESS (Epworth sleepiness score) in relation to active treatment vs. placebo, Difference in Spirometry (FEV1, FVC, FEV1/FVC (ratio)) in relation to active treatment vs. placebo, Difference in 6MWT (Six-minute walk test including BORG score) in relation to active treatment vs. placebo, Difference in hair cortisol level in relation to active treatment vs. placebo, Difference in parameters from Empatica Embrace watch (such as continuous measurement of SpO2 (blood oxygen saturation), EDA (electro

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 18, 2026