Effect of PIFR-based optimised inhalation therapy in patients recovering from acute exacerbation of chronic obstructive pulmonary disease: Protocol of a prospective, multicentre, superiority, randomised controlled trial

Abstract

Introduction Acute exacerbation (AE) is a major cause of disease progression and death in patients with chronic obstructive pulmonary disease (COPD), accounting for majority of medical expenditures. Correct inhalation therapy is effective in preventing AE attacks. However, inappropriate usage of dry powder inhaler, partially due to the unrecovered peak inhalation flow rate (PIFR) after acute exacerbation of COPD (AECOPD), results in increased risk of early treatment failure. Therefore, we designed a multicentre, randomised clinical trial to determine whether PIFR-based optimised inhalation therapy and training on inhaler usage at discharge could effectively reduce early treatment failure events. Methods and analysis A total of 416 hospitalised patients just recovering from AECOPD will be recruited and equally randomised into the PIFR group and the control group at a 1:1 ratio. The PIFR group will receive additive support before discharge, including choice of PIFR-guided inhaler and education on its usage. PIFR is measured by InCheck DIAL. In comparison, the control group will receive inhalers based on judgement of the respiratory physician. The primary outcome of the study is 30-day treatment failure rate. Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs. Ethics and dissemination The trial has been approved by the Ethics Committee of Zhongshan Hospital of Fudan University (B2019-142). Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment. After the trial has completed, the results will be reported to the public through conference presentations and peer-reviewed journals. Trial registration number NCT04000958.