Assessment of Inhaler Technique in Asthma and COPD Clinical Trials

The use of correct inhaler technique is rarely checked, optimized, or reported among patients with asthma or COPD who take part in randomized controlled trials (RCTs) involving the use of inhalers at baseline and some form of escalation treatment, according to a systematic review that was recently in The Journal of Allergy and Clinical Immunology: In Practice.  The article also included a Best-Practice Inhaler Technique Assessment & Reporting Checklist.

Correct use of inhalers is fundamental to controlling airway disease, yet past research has indicated that inhaler technique errors are made by 90% of patients, noted review authors. Such technique errors can affect the accuracy of results of RCTs for asthma and COPD that involve inhaler use, potentially offering a false indication for the need for escalating biological therapies. Moreover, the extent to which inhaler technique is checked and optimized in RCTs is unclear due to a lack of reporting or guidelines on this subject.

Researchers noted that “if assessment and optimization of inhaler technique are not being carried out as part of the study protocol in the majority of relevant RCTs of asthma and COPD therapy, this detracts from the credibility of the data and the robustness of the conclusions.”

The current systematic review sought to assess how frequently inhaler technique is evaluated and optimized in RCTs concerning asthma and COPD therapy. The review authors searched PubMed and EMBASE databases to discover 1014 studies published in the past decade concerning patients with asthma or COPD that involved a change from their baseline inhaled therapy, including the addition of biological agents. Screening, text review, and removal of duplicates left 118 studies for analysis. Of these, only 14 studies (11.9%) included information regarding assessment of inhaler technique among participants.

Review authors noted that “while there is an implicit duty of care to ensure correct inhaler technique in any clinical setting, there are no existing standards governing their frequency and quality.” To address this problem, the review authors proposed a Best-Practice Inhaler Technique Assessment & Reporting Checklist to be used for RCTs.

Researchers concluded that their study “identifies a concerning lack of checking and correcting inhaler technique, or at least reporting that this was undertaken, prior to enrollment in asthma and COPD RCTs, which may impact on the conclusions drawn.” They urge the mandating of “a standardized checklist in RCT protocols and ensuring all published RCTs report checking and correcting inhaler technique prior to enrollment.”

Disclosure: This research was supported by industry (Chiesi Farmaceutici S.p.A.). Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Dekhuijzen PNR, Levy ML, Corrigan CJ, et al; ADMIT Working Group. Is inhaler technique adequately assessed and reported in clinical trials of asthma and COPD therapy? A systematic review and suggested best practice checklist. J Allergy Clin Immunol Pract. Published online March 29, 2022. doi:10.1016/j.jaip.2022.03.013