Tomisa G1,2*, Horváth A1,2, Sánta B1, Kovács T1, Szabó M3, Lovász O4, Müller V2 and Tamási L2
1Chiesi Hungary Ltd, Hungary 2Department of Pulmonology, Semmelweis University, Hungary 3Robert Koch Hospital and Outpatient Clinic, Hungary 4Health Centre and Outpatient Clinic of Komló, HungaryFulltext PDF
Aim: There is a lack of knowledge of the efficacy of single inhaler triple combination therapy in patients with moderate COPD. Subjects and Methods: RATIONALE is a 52-week, ongoing phase IV, multicentre, prospective clinical trial evaluating the efficacy of single inhaler triple therapy BDP/FF/GB in patients with moderate COPD. The main eligibility criteria were age ≥ 35 years, 50% ≤ FEV1 <80%, CAT score ≥ 10 or mMRC ≥ 2 and ≥ 2 exacerbations/year. Changes in the treatment of patients had to happen before and irrespective of study inclusion. A pre-planned interim analysis of the first two visits was conducted 1 year after the start of the study. Results: As of data cut-off (March 18th, 2021), 616 patients were enrolled in the study and 498 patients were included in this analysis. 91 patients (18.3%) had received ICS-LABA, 140 patients (28.1%) open triple combination and 267 (53.6%) patients LABA-LAMA as previous therapy. The proportion of patients not reporting cough/sputum production increased by 9.05% and 19.68%, respectively (p<0.0001). The proportion of patients not reporting any limitations increased in all EQ-5D-3L domains (p<0.0001). The average mMRC scores decreased significantly (p<0.0001). The mean values in the CAT and VAS scores improved in all FEV1 groups (p<0.0001). Conclusion: In this interim analysis, significant improvements were seen in all of the assessed parameters, showing a clear benefit for extrafine single inhaler triple therapy use in patients with moderate COPD who were symptomatic on previous dual or open triple therapy.
COPD; Fixed triple combination; Real-world study; Adherence; Symptom scores; Quality of life
Tomisa G, Horváth A, Sánta B, Kovács T, Szabó M, Lovász O, et al. Rapid Improvement of Symptom Scores and QoL on Short-Term with Extrafine Fixed Triple Inhaled Therapy and Patient Characteristics in Moderate COPD in a Real-Life Setting. Ann Clin Case Rep. 2022; 7: 2232..