Optimizing maintenance therapy in patients with COPD: Protocol of a real-world observational study of peak inspiratory flow rate, inhalation technique and medication adherence (PIFotal COPD study)

Research question: What are the associations among Peak Inspiratory Flow Rate (PIFR), inhalation technique, and medication adherence with health status and exacerbations in patients with COPD receiving maintenance therapy by Dry Powder Inhalers (DPIs). Background: Effectiveness of maintenance therapy for COPD with DPIs requires patients to be able to produce optimal PIFR, employ a suitable inhalation technique and have adequate medication adherence. Yet, in primary care, little is known about the association between these factors and health status in patients with COPD. Methods: Cross-sectional observational study in the Netherlands, Spain, Portugal, Greece, Poland and Australia. The participants (N=1200) will be assessed once in their general practitioner’s office or pharmacy (visit duration maximum 60 minutes). The assessments will consist of 1. Three PIFR measurements (typical PIFR against the resistance of own inhaler; maximal PIFR against the resistance of own inhaler; maximal PIFR against low resistance) 2. Three questionnaires (Clinical COPD Questionnaire, COPD Assessment Test, Test of Adherence to Inhalers) and 3. Video recording of patient’s inhalation technique. Eligibility criteria: clinical diagnosis of COPD; 40 years or older, receiving maintenance therapy using a DPI for at least 3 past months. Immediately after the measurements, patients who manifest inhalation errors, will receive tailored inhalation instruction. Questions to discuss: Would this research setup work in your own country? How can the patient-inhaler match be improved? How many patients exhibit critical inhalation errors and how can inhalation technique education be improved? What are the predictors of optimal DPI use and how can this knowledge be used to improve the effectiveness of COPD maintenance therapy in primary care? Declaration of Interest The study (trial registration: NCT04532853) sponsor is the General Practitioners Research Institute; data collection and analysis will be performed by General Practitioners Research Institute. Boehringer Ingelheim is the funding and scientific partner. References and Clinical Trial Registry Information Trial registration: NCT04532853