The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol

Int J Chron Obstruct Pulmon Dis. 2021 Jan 27:16:159-166. doi: 10.2147/COPD.S286559. eCollection 2021.

Abstract

Background: The fixed triple combination Beclometasone dipropionate/Formoterol fumarate/Glycopyrronium (BDP/FF/G, Trimbow®), an extrafine formulation in a unique pressurized metered dose inhaler, is indicated for the maintenance treatment in adult patients with moderate to severe COPD, not adequately treated by ICS/LABA or LABA/LAMA. Besides the evidence from three randomized controlled trials, the impact of fixed triple therapy has not been extensively evaluated in a real-world population of COPD patients. TRITRIAL (TRIple Therapy in Real life: Impact on Adherence and HeaLth status) is a non-interventional study to assess the effect of BDP/FF/G in a real world setting in Italy.

Design: TRITRIAL is a 12-month, multicenter, cohort, prospective, longitudinal observational study. Two follow-up visits will be performed at 6 and 12 months, respectively. The study includes the collection of anamnestic clinical and functional data before the start of BDP/FF/G. The study is built for digital conduction, from signature of the informed consent on a dedicated web platform, to the collection of questionnaires and clinical data on the eCRF.

Population: A total of 800 patients with COPD ranging from Global Initiative for Obstructive Lung Disease (GOLD) stages 2 to 4, receiving therapy with BDP/FF/G according to the Summary of Product Characteristics and local clinical practice, will be recruited. All concomitant therapies will be permitted for the duration of the study.

Evaluations: The primary endpoint is the change of CAT score at 12 months versus baseline. Secondary endpoints are adherence, health-related quality of life, sleep quality, disease-related outcomes (lung function and COPD exacerbations), device usability, economic resources consumption, and safety.

Conclusion: TRITRIAL study is expected to give relevant information about effectiveness of BDP/FF/G fixed triple therapy in a real-life setting of patients with COPD, where adherence, usability of inhalers and patient's preference of the device are crucial factors for the success of the therapy.

Keywords: COPD; ICS; LABA; LAMA; adherence; health status; symptoms.

MeSH terms

  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists / adverse effects
  • Adult
  • Beclomethasone* / adverse effects
  • Drug Combinations
  • Formoterol Fumarate / adverse effects
  • Glycopyrrolate / adverse effects
  • Health Status
  • Humans
  • Italy
  • Multicenter Studies as Topic
  • Muscarinic Antagonists / adverse effects
  • Observational Studies as Topic
  • Prospective Studies
  • Pulmonary Disease, Chronic Obstructive* / diagnosis
  • Pulmonary Disease, Chronic Obstructive* / drug therapy
  • Quality of Life
  • Treatment Outcome

Substances

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