The Real-World Efficacy of Fixed Triple Inhalation Therapy in the Treatment of Moderate COPD Patients (RATIONALE Study)

Abstract

András Südi,1 Balázs Sánta,2,3 Alpár Horváth,1,2 Gábor Tomisa,1 Zsolt Abonyi-Tóth,4,5 György Rokszin,4 Noémi Eszes,1 Veronika Müller,1 Lilla Tamási1 1Department of Pulmonology, Semmelweis University, Budapest, Hungary; 2Medical Department, Chiesi Hungary Kft, Budapest, Hungary; 3Department of Pulmonology, Szent Borbála County Hospital, Tatabanya, Hungary; 4Rx Target Kft, Budapest, Hungary; 5Department of Biostatistics, University of Veterinary Medicine, Budapest, HungaryCorrespondence: Lilla Tamási, Department of Pulmonology, Semmelweis University, Tömő Str. 25-29, Budapest, 1083, Hungary, Fax [phone], Email [email protected]: 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.Patients and Methods: 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.Results: 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.Conclusion: 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.Keywords: COPD, fixed triple combination, inhalation treatment, quality of life

Keywords

• copd
• fixed triple combination
• inhalation treatment
• quality of life