Serial Lung Function Measurements in Healthy and Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT) Administered With the Respimat® B (RMT-B)

Condition:   Asthma
Interventions:   Drug: BHT 0.1%;   Drug: BHT 0.5%;   Drug: Placebo for RMT-B;   Drug: Placebo for HFA-MDI
Sponsor:   Boehringer Ingelheim
Completed – verified August 2014

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Differences in serial lung function recorded on four data-logging meters.

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Differences in serial lung function recorded on four data-logging meters.

J Asthma. 2013 Jul 19;

Authors: Adeniyi BO, Moore CV, Erhabor GE, Burge S

Abstract Introduction Lung function measurements performed several times daily are useful for the diagnosis of occupational asthma. Patient fabrication of hand-recorded charts can limit confidence in the results; this is overcome using electronic meters that log time and measurement. We have compared individual and meter differences in FEV1 and PEF recorded by hand and from meter logs using expert subjects on 4 data-logging spirometers with different methods of measurement and different quality control software. Method Eight workers in a respiratory physiology department were asked to record FEV1 and PEF 2-hourly from waking for 7 days using 4 electronic meters (Easyone, Micro DL, Vitalograph Diary card 2110 and Piko-1) in random order. Subjects hand-recorded the best FEV1 and PEF from each session, this was compared with the logged data. Results Discordant measurements from individuals were lower for FEV1 than PEF and differed from 4.4-19.1% for FEV1 (mean 9.4%, p<0.0001) and 6-23.3% for PEF (mean 12.6, p<0.0001). There were also significant differences between meters for both variables (p<0.0001). The magnitude of the differences in PEF was highest for the Easyone (34 litres/min) and lowest for the Vitalograph Diary card 2110 (14 litres/min) and varied significantly between meters (mean 22 L/min, p=0.002). Conclusion Differences between hand-recorded and logged measurements are unlikely to be due solely to patient fabrication and can be due to quality criteria or other unclear software requirements applied after the results are shown on the meter screen; they differ between meters. Whether the differences shown affect clinical outcome will require further investigation.

PMID: 23865815 [PubMed – as supplied by publisher]

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