Inhaler technique is not assessed in most asthma and COPD clinical trials
Published: March 29, 2022
Inhaled medications are central to the treatment of asthma and chronic obstructive pulmonary disease (COPD), yet research shows that poor inhaler technique is a common problem. Indeed, some studies suggest that critical mistakes when using inhalers, making them potentially useless, are made by as many as 90% of patients suffering with asthma and COPD. Poor inhaler technique reduces the quantity of medication reaching the airways, which reduces symptom control and increases the risk of exacerbations, unnecessary suffering and the use of healthcare facilities and associated costs.
Recruitment of patients whose asthma and COPD is not controlled as well as it might be because of poor inhaler technique into clinical trials of new treatments for these diseases, especially if these new treatments do not require inhalation, may result in misleading conclusions about their effectiveness and overall potential benefits (if any). In a new study published in The Journal of Allergy and Clinical Immunology: In Practice, Professor Richard Dekhuijzen and colleagues from the ADMIT group have taken a careful and comprehensive look at how often and how well inhaler technique is examined and optimized at the time of enrollment of patients into asthma and COPD clinical trials.
The researchers looked at all asthma and COPD clinical trials published in the past 10 years by systematically searching the world literature. They identified over 1,000 such trials, 118 of which required patients to increase and/or change their inhaled therapy or in addition commence new biological agents.
Professor Dekhuijzen and his research team found that, in a staggering 88% of the clinical trials they examined, there was no documentary evidence that the inhaler technique of the participants had been assessed at any time, let alone optimized. In fact, only 14 of these trials included accessible information about assessment of the patients’ inhaler technique, either in the trial report itself or in online supplements or protocols. To address this critical deficit in asthma and COPD clinical trial methodology, the authors developed a new ‘Best-Practice Inhaler Technique Assessment & Reporting Checklist’ assimilating all critical aspects of inhaler technique by incorporating elements such as checking whether patients can achieve sufficient inspiratory flow, where necessary, to use a particular device, are sufficiently dexterous to prime (handle, load, and shake) it and exhibit coordination and fluidity when performing the inhalation maneuver. It also ensures that the study protocol incorporates a record of this assessment, on repeated occasions if appropriate, the qualifications of the assessor and the evidence of how and when the patient’s technique was verified as adequate throughout the study. The researchers anticipate that this checklist will be a useful tool to guide the development of study protocols, best-practice reporting and facilitate a standardized approach across studies.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.