Abstract
BackgroundThe primary lung function endpoint in clinical trials in adolescent and adult patients with asthma is usually forced expiratory volume in one second (FEV1). The objective of our analysis was to assess whether peak expiratory flow (PEF) is a suitable alternative primary lung function endpoint.MethodsFor this assessment, we calculated post hoc the correlation between pre-dose FEV1 and pre-dose PEF measured under supervision in the clinic and, for both lung function parameters, the correlations between supervised clinic and unsupervised home measurements, using the results from the 8 Phase III parallel-group trials of the global clinical development programme with tiotropium Respimat® in patients with asthma aged 12 to 75 years.ResultsAcross all 8 trials included in this analysis, changes in lung function from baseline correlated well between pre-dose FEV1 and pre-dose PEF when both were measured under supervision in the clinic. Correlation between supervised in-clinic and unsupervised home measurements was stronger for pre-dose PEF than for pre-dose FEV1.ConclusionsPre-dose PEF measured at home could be an alternative primary lung function endpoint for trials in adolescent and adult patients with asthma. Using home-measured PEF could facilitate trial conduct and improve the convenience for patients by relocating scheduled assessments from the clinic to the patient’s home.Trial registrationAdolescents aged 12 to 17 years: RubaTinA-asthma® (NCT01257230), PensieTinA-asthma® (NCT01277523).Adults aged 18 to 75 years: GraziaTinA-asthma® (NCT01316380), MezzoTinA-asthma® (NCT01172808/NCT01172821), CadenTinA-asthma® (NCT01340209), PrimoTinA-asthma® (NCT00772538/NCT00776984).All from Clinicaltrials.gov (https://clinicaltrials.gov/).
Highlights
The primary lung function endpoint in clinical trials in adolescent and adult patients with asthma is usually forced expiratory volume in one second (FEV1)
Lung function in terms of Forced expiratory volume in 1 s (FEV1) and peak expiratory flow (PEF) at baseline was in line with the different ranges of asthma severity
Our results indicated a strong association between pre-dose FEV1 and pre-dose PEF when both parameters were measured under supervision in the clinic, with the Pearson correlation coefficient (PCC) being greater than 0.773 across all trials and all time points
Summary
The primary lung function endpoint in clinical trials in adolescent and adult patients with asthma is usually forced expiratory volume in one second (FEV1). Pre-bronchodilator FEV1, i.e. the FEV1 recorded after withholding bronchodilators for their duration of action, is a strong, independent predictor of future exacerbation risk, and has been used in the majority of asthma clinical trials as the primary lung function endpoint in recent decades [1]. This is in line with regulatory recommendations for clinical trials in asthma that consider prebronchodilator FEV1 as the most suitable variable [2].
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