COPD Treatment Trial Data for Fluticasone Furoate/Vilanterol

60 patients with moderate-to-severe COPD were randomized in a 4-week, placebo-controlled trial to assess the efficacy and safety of a once-daily fluticasone furoate/vilanterol (FF/VI) inhaler. The dataset contains results from co-primary endpoints like weighted mean heart rate and adverse event incidence, and secondary endpoints including trough and weighted mean FEV1 measurements. It was authored by Jan Lötvall and published in 2019.

Use Cases

• Analyze the incidence of adverse events (AEs) like oral candidiasis and dysphonia between the FF/VI and placebo groups.
• Model the relationship between changes from baseline in weighted mean FEV1 (0–4 h postdose) and treatment assignment.
• Compare the safety profile by examining changes from baseline in weighted mean heart rate (0–4 h postdose) across patient cohorts.
• Investigate the efficacy signal by evaluating the mean difference in trough FEV1 (23–24 h postdose) between treatment arms.

Strengths

• Data originates from a multicentre, randomised, double-blind, parallel-group, placebo-controlled clinical trial, a robust study design.
• Includes results for 60 randomized patients, with a 2:1 allocation ratio (40 FF/VI, 20 placebo) providing a clear treatment comparison.
• Reports specific, statistically significant efficacy results, such as a 183 ml mean difference in trough FEV1 favoring the FF/VI group.

Limitations

• Small sample size of 60 patients limits the statistical power to detect rare adverse events or subgroup differences.
• Short 4-week treatment duration does not capture long-term safety outcomes or sustained efficacy of the intervention.
• Patient population is limited to those with moderate-to-severe COPD, restricting generalizability to other disease severities.

Provenance

Source

Dryad digital repository.

Collection Method

Collected via a multicentre, randomised, double-blind, parallel-group, placebo-controlled clinical trial.

Time Range

Covers a 4-week treatment period, with endpoints measured at day 28 and day 29.

Freshness

Data was last updated in 2019, representing a snapshot from a completed clinical trial.

Geography

Multicentre trial; specific geographic locations are not provided in the input.