Triple therapy improves health status of COPD patients in real-world setting

Treatment with budesonide/glycopyrronium/formoterol (BGF), a triple therapy delivered via metered-dose inhaler (MDI), improves health status in Chinese patients with chronic obstructive pulmonary disease (COPD), based on real-world data presented at APSR 2024.

The researchers conducted a multicentre, prospective, observational, single-arm study involving 3,317 patients aged 50 years (82.9 percent male) with COPD, of whom 51.3 percent had high exacerbation risk (≥1 severe or ≥2 moderate exacerbations in the past year), recruited from 42 sites in China. The participants were prescribed with BGF and were followed up every 4 weeks for 12 weeks. The COPD Assessment Test (CAT) and St George’s Respiratory Questionnaire (SGRQ) scores were used to assess patients’ health status. [APSR 2024, abstract AP09-015]

After a 12-week treatment with BGF, the mean change in CAT total scores decreased by 4.6, 6.1, and 6.7 at weeks 4, 8, and 12, respectively, as did the SGRQ total scores (11, 13.6, and 14.5, respectively), indicating a decline and sustained trend from baseline.

In a subgroup analysis, consistent reductions in mean CAT and SGRQ total scores from baseline were observed regardless of whether the patients had baseline CAT total scores of <10 (0.1 [CAT] and 3.9 [SGRQ] at week 4 and 0.9 [CAT] and 3.5 [SGRQ] at week 12) or ≥10 (5.4 [CAT] and 12.2 [SGRQ] at week 4 and 7.8 [CAT] and 16.5 [SGRQ] at week 12).

Decreased mean CAT and SGRQ total scores were also observed in patients with high (4.8 and 11.9, respectively, at week 4 and 7.0 and 15.3 at week 12) or low exacerbation risks (4.3 and 10.0, respectively, at week 4 and 6.5 and 13.8 at week 12).

Taken together, mean reductions in CAT and SGRQ total scores were consistently observed across all subgroups.

In terms of lung function, a total of 241 patients demonstrated improvements, as indicated by an increase of 189 mL in pre-dose FEV₁ from baseline to week 12.

“Overall, real-world results confirmed BGF improved health status and lung function over 12 weeks,” said the researchers.

Real-world safety data

Another study assessed the incidence of adverse events (AEs) and serious AEs following BGF treatment in the same population. [Eur Respi J 2024;64(suppl 68):PA2999]

AEs occurred in 23.9 percent of patients treated with BGF, while only 4.9 percent had serious AEs.

Pneumonia (1.8 percent), hypokalaemia (1.6 percent), and upper respiratory tract infection and dysphonia (1.4 percent each) were the most common AEs, which were mostly considered mild or moderate.

“BGF MDI was safe and well-tolerated in real-world clinical practice and most patients were satisfied with the device,” the researchers noted.