COPD affects more than 300 million people worldwide, requiring inhalation treatment.
Novel triple formulations of ICS, LABAs and LAMAs are becoming the mainstay of treatment,
however there is still a lack of clinical evidence for personalized therapy.RATIONALE
was a non-interventional, prospective, 52 week study, assessing the effectiveness
of beclometasone/formoterol/glycopyrronium-bromide (BDP/FF/G), in symptomatic COPD
patients, with moderate airflow obstruction. The study included 4 visits, where data
on demographic parameters, exacerbations, symptoms, quality of life (based on the
EQ-5D-3L questionnaire) and lung function were collected. Data on adherence to treatment,
based on prescriptions filled was collected from the database of the National Health
Insurance Fund, with the patients' consent. The primary objective was the change of
adherence to treatment during the study, compared to baseline.Altogether 613 patients
had been enrolled. Their average age was 64.56 years and 50.5% were female. The average
CAT score was 20.86, and most patients had suffered minimum one exacerbation (82.2%).
Average FEV1 was 59.6%. Most patients had some limitation in one or more dimensions
of EQ-5D-3L, with an average visual analogue scale score (VAS) of 60.31. After 12
months of treatment, adherence improved significantly - proportion of patients in
the highest adherence group increased from 29.8% to 69.7% (p<0.001). The average CAT
score improved by 7.02 points (95% CI 5.82-8.21, p<0.001). There was a significant
improvement in all dimensions of EQ-5D-3L, with an average increase of 17.91 (95%
CI 16.51-19.31, p< 0.001) points in the VAS score. Exacerbation frequency also decreased
significantly.Although limitations of observational studies are present, we observed
that early introduction of fixed triple combination results in a marked improvement
in adherence to treatment, symptom scores, exacerbation frequency and quality of life.
The optimal choice of treatment is crucial for reaching the highest possible adherence.