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

Int J Chron Obstruct Pulmon Dis. 2024 Aug 28:19:1943-1955. doi: 10.2147/COPD.S474354. eCollection 2024.

Abstract

Purpose: 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.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists* / administration & dosage
  • Aged
  • Beclomethasone* / administration & dosage
  • Bronchodilator Agents* / administration & dosage
  • Disease Progression
  • Drug Combinations*
  • Female
  • Forced Expiratory Volume
  • Formoterol Fumarate* / administration & dosage
  • Glucocorticoids / administration & dosage
  • Glycopyrrolate* / administration & dosage
  • Humans
  • Lung* / drug effects
  • Lung* / physiopathology
  • Male
  • Medication Adherence*
  • Middle Aged
  • Muscarinic Antagonists* / administration & dosage
  • Muscarinic Antagonists* / adverse effects
  • Prospective Studies
  • Pulmonary Disease, Chronic Obstructive* / diagnosis
  • Pulmonary Disease, Chronic Obstructive* / drug therapy
  • Pulmonary Disease, Chronic Obstructive* / physiopathology
  • Quality of Life*
  • Recovery of Function
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome

Substances

  • Drug Combinations
  • Bronchodilator Agents
  • Glycopyrrolate
  • Adrenergic beta-2 Receptor Agonists
  • Muscarinic Antagonists
  • Beclomethasone
  • Formoterol Fumarate
  • Glucocorticoids

Grants and funding

The study was funded by Chiesi Hungary Kft.