BONG Clinical Trial

Uses

How it works

Comparisons

Evidence quality

Highlighted claims

• Primary and secondary outcomes are analysed using mixed-effects linear models following the intention-to-treat principle. — 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
• The BONG study is a single-centre, randomised, double-blinded, placebo-controlled crossover trial conducted in an outpatient clinic in Denmark. — 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
• The crossover design allows each patient to serve as their own control, reducing interindividual variability and increasing statistical power compared to a parallel-group design. — 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
• A 2-week washout period between treatment arms is included to reduce the risk of carryover effects distorting results. — 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
• The planned sample of 30 patients accounts for a 25-30% dropout rate typical of COPD studies; 20 patients are calculated as statistically sufficient. — 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
• The BONG trial differs from earlier THC studies by focusing specifically on patients with severe and very severe COPD and substantial breathlessness. — 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