[Chinese expert consensus on standardized inhaler device application in stable chronic airway diseases (2023)].

The incidence of chronic airway diseases in China has been increasing every year, resulting in a high burden of disease. Inhalation therapy is widely used as a basic first-line treatment for such diseases. However, inappropriate selection of inhalation devices and usage methods is common, leading to poor disease control and prognosis, as well as a waste of medical resources. In order to facilitate the reasonable selection and appropriate use of inhaler devices, improve the efficacy of inhalation therapy, and increase patient compliance, the Inhalation Therapy and Respiratory Rehabilitation Group, Respiratory Equipment Committee of China Association of Medical Equipment, and Chinese Chronic Obstructive Pulmonary Disease Coalition organized experts to revise the Chinese expert consensus on standardized inhaler device application in stable chronic respiratory disease patients (2019 Edition) based on the latest evidence-based medical evidence and clinical diagnosis and treatment experience.Chronic airway diseases can affect the anatomical and physiological structure of the respiratory tract, which can affect the inhalation and delivery of drugs. In order to achieve the maximum effect of inhaled drugs, it is necessary for the drugs to be completely released from the device and to be deposited in the peripheral airways. Therefore, inhaler devices, patients, and medical staff can have a significant impact on the effectiveness of inhalation administration. The effectiveness of inhalation administration is influenced by several factors related to the inhaler device itself, including active or passive release, aerosol characteristics, and internal device resistance. For patients, the inhalation ability, the correct use of inhaler devices (inhalation technique), and regular and quantitative inhalation (treatment compliance) are essential to achieve the desired therapeutic effect. Medical staff can influence the efficacy and compliance of patients through proper assessment of their inhalation capacity and preferences, knowledge of different inhaler device characteristics, rational selection of inhaler devices, training in inhalation techniques, and guidance on inhaler device replacement. Standardized education can help minimize operational errors and improve patients' ability to use inhaler devices effectively. In addition, deep inspiratory volume, prolonged breath-hold time, airway clearance, and reduction of upper airway curvature and resistance can further improve the efficacy of inhaled drugs. The choice of inhalation device should be based on the patient's inspiratory flow rate, hand-lung coordination ability, device operation ability, and preference.The revised consensus version provides a clear understanding of the characteristics and operating principles of different types of inhaler devices, including pressurized metered-dose inhaler (pMDI), dry powder inhaler (DPI), soft mist inhaler (SMI), and small-volume nebulizers (SVN). The consensus categorizes pMDI as traditional pMDI (solution type, suspension type, and co-suspension type), extra-fine pMDI, and breath-actuated pMDI; and DPI into capsule, reservoir, and blister types. The inhalation device is evaluated based on three dimensions: drug delivery, device operation, and other characteristics. The indicators to assess drug delivery characteristics include lung deposition, oropharyngeal deposition, aerosol duration, aerosol plume velocities, MMAD, fine particle fractions, and dose repeatability. The indicators used to assess the operational device characteristics include inspiratory flow rate requirements, hand-breath coordination requirements, inspiratory synchronous drive, pre-use shaking, and operational steps. Other characteristic indicators include avoidance of humidity exposure, storage environment requirements, propellant, carrying convenience, counter, cleaning, and medication type. The consensus provides a detailed introduction to the personalized selection, switching, education, and follow-up of inhaler devices.1. Establishing a Chinese consensus on the individualized selection of inhaler devices for patients based on the characteristics of different devices includes the following steps:(1) Testing the patient's hand-breath coordination using an active release inhaler device (recommended: a short-acting bronchodilator inhaler). If the device is being used for the first time or is not being used correctly, it should be re-tested after instruction.(2) Testing the patient's peak inspiratory flow rates and whether they can consistently inhale at an inspiratory flow rate of 30 L/min for 3 seconds (an alternative assessment method is to continue eating yoghurt through a straw).(3) Assessing the need for non-invasive ventilation in patients with poor hand-breath coordination.(4) Based on the evaluation results, the recommendations for different inhaler devices are as follows:① Patients with good hand-breath coordination and the ability to inhale consistently at an inspiratory flow rate of 30 L/min (or more) for more than 3 seconds can use any inhaler device; ② Patients with poor hand-breath coordination who can achieve a peak inspiratory flow rate of 30L/min can use DPI or an active release device with a Spacer; ③ Patients with good hand-breath coordination, a peak inspiratory flow rate less than 30 L/min, and a constant inspiratory flow for more than 3 seconds can use SMI or an active release device with a Spacer; ④ Patients with poor hand-breath coordination, a peak inspiratory flow rate less than 30 L/min, and a constant inspiratory flow for more than 3 seconds can use SMI and an active release device with a Spacer; ⑤ Patients with a peak inspiratory flow rate less than 30 L/min and a constant inspiratory flow for less than 3 seconds can use an active release device with a Spacer; ⑥ Patients who require non-invasive ventilation can use an active release device and nebulizers(Active release devices include pMDI and SMI).2. Switching inhaler devices:The need to switch inhaler devices should be clear, and there are indications for switching:(1) inhaled drugs has been changed or added because of the patient's condition, requiring delivery by another inhaler device.(2) the patient was unable to use the inhaler device correctly after several training attempts.(3) patients were dissatisfied with the inhaler device and had poor adherence.(4) the patient used the device correctly, but the therapeutic effect was unsatisfactory.Once the decision to switch the inhaler device has been made, the following steps should be taken:(1) explain the necessity of switching the inhaler device.(2) retrain the patient in the use of the new inhaler device.(3) intensify follow-up to obtain patient feedback on the use of the new device and to check inhalation technique, drug consumption and efficacy.3. Education on inhalation technique:It is crucial to educate patients on proper inhalation technique. Teaching patients how to use inhaler devices in a standardized way is an important measure to ensure that they use the devices correctly. This helps to improve the accuracy of inhaler device operation, patient adherence, disease control, and reduce disease burden. Relying solely on the instructions provided with the inhaler device is not sufficient to adequately educate patients, and patients' inhalation technique may unintentionally change over time, resulting in decreased efficacy. Inhalation technique should be regularly reviewed and corrected at each visit.4. Follow-up of inhalation therapy:Follow-up management is a crucial part of maximizing patient efficacy, including assessing efficacy, correcting operation techniques, and promoting adherence.5. Other:When patients with chronic airway diseases are at risk of respiratory epidemic infectious diseases, the use of inhaler devices should strictly comply with the requirements for the prevention and control of such diseases.