Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV₁.

ABSTRACT:

Background

The 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.

Methods

For 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.

Results

SUBMITTER: Halpin DMG 

PROVIDER: S-EPMC6637596 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature