Clinical impact of pharmaceutical consultations in patients treated for chronic obstructive pulmonary disease: Study protocol for a randomized controlled trial (BPCObs study)

Background: Chronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory disease which outcome depends on medication adherence. Pharmacists may increase this adherence by advising patients on inhaler devices proper use. This paper presents the protocol for a randomized controlled trial, which assesses impact of pharmaceutical consultations on COPD exacerbations, medical care, adherence to inhaler devices and quality of life. Methods: This trial will include 226 COPD patients treated with inhaler devices: 94 in a control group, 66 receiving a pharmaceutical consultation at hospital and 66 receiving up to 12 pharmaceutical consultations corresponding to dispensing at their community pharmacy. The aim of these interventions is to inform patients about COPD medication, train them in the use of inhaler devices and improve adherence. Patients included by hospital pharmacist will be randomly assigned to the control and hospital experimental groups. Community pharmacists (CP) will include patients in the experimental community group. CPs will follow-up all study patients for 12 months. Primary outcome is the mean number of COPD exacerbations. Secondary outcomes include number of medical consultations, emergency visits and hospitalizations, patients’ adherence devices and quality of life. Discussion: This is the first French trial which assesses both hospital and community pharmaceutical interventions on COPD patients. Study limitations include recruitment and CP adherence to follow-up. Indeed, the success of this trial depends on the willingness of CPs to collect the data. This work is the first step towards building a network of CPs trained for clinical research. Trial registration: Clinicaltrials.gov, NCT03704545. Registered on October 12th, 2018. https://clinicaltrials.gov/ct2/show/NCT03704545?cond=COPD&cntry=FR&city=nimes&draw=2&rank=1.