Oscillometry in the COPD Exacerbator Phenotype With Triple Inhaled Therapy Study

Chronic obstructive pulmonary disease (COPD) is the most prevalent chronic respiratory disease worldwide, estimated at around 12% in Spain and 17.3% in Catalonia, despite significant underdiagnosis of up to approximately 74%. It is associated with high morbidity and mortality, being considered the third leading cause of death worldwide in 2021. Currently, spirometry represents the most standardized and well-known instrument for the diagnosis, control, and monitoring of COPD. However, the implementation of new tools is necessary to better define the characteristics of the disease and optimize its treatment. Furthermore, oscillometry is considered a quick and easy respiratory function test that allows the assessment of bronchial obstruction and emphysema by measuring pulmonary resistance and reactance, even in patients with normal spirometry. Its use in patients with asthma has allowed for comparisons of changes in airway obstruction with different inhaled corticosteroid (ICS) particles, with the aim of optimizing treatment choice. Therefore, its implementation in the study of patients diagnosed with COPD could also be very useful in this regard.

Main objective: To evaluate, using oscillometry, the therapeutic effectiveness of inhaled corticosteroids within triple closed therapy (LABA/LAMA/ICS) in a single device, compared to dual bronchodilation (LABA/LAMA), as maintenance treatment in patients with COPD exacerbators.

Methodology: This is an observational, prospective, multicenter study to be conducted in six hospitals in Catalonia, Spain. The goal is to include 63 patients diagnosed with COPD exacerbators, receiving dual bronchodilation treatment and meeting the endpoints for initiation of triple inhaled therapy, according to clinical practice guidelines (GesEPOC 2021, GOLD 2023). The device will be selected based on medical criteria, using the various closed-loop triple therapy inhalers currently available on the market. An initial oscillometry test will be performed to classify patients according to the predominant pattern: central obstruction, peripheral obstruction, and/or pulmonary hyperinflation. This initial measurement will be taken prior to changing treatment and immediately after the first dose of the new triple therapy inhaler. Subsequently, during patient follow-up, oscillometry will be repeated at 2, 4, and 12 weeks. The quality of life questionnaire (QLQ) and the inhaler adherence test will be self-administered at each visit. Data will be collected from the patients' electronic medical records and from laboratory tests performed during the previous year.

• Spirometric results [Срок оценки: initial and at visit 3 (baseline and week 12)]
• COPD Assessment Test (CAT) [Срок оценки: on each of the 3 visits (baseline, week 4, week 12)]
• Test of Adherence of Inhalers (TAI) [Срок оценки: on each of the 3 visits (baseline, week 4, week 12)]
• Spirometric results (forced expiratory volume in 1 second to forced vital capacity ratio) [Срок оценки: initial and at visit 3 (baseline and week 12)]