Abstract
Introduction
In clinical trials, spirometry measurements may be taken at home using electronic diaries (e-Diaries) with integrated spirometers, for use as safety and/or efficacy endpoints. The accuracy of this data is of particular importance1. Previous clinical trials have used an older Vitalograph e-Diary, where limited feedback was given to patients.
Aim
To determine the repeatability of domiciliary PEF and FEV1 data collected using the new Vitalograph In2itive e-DiaryTM in an international multi-centre, double blind, placebo controlled clinical trial in patients with asthma.
Method
174 patients were instructed by trained staff to record spirometry measurements at home, twice a day.
If the patient did not meet the ATS/ERS 2005 Repeatability criteria, the e-Diary provided instant feedback that the respiratory efforts were not consistent and asked the patient to perform another test.
Results
Repeatability Criteria:
PEF: 2 highest results < 40 L/min difference
FEV1: 2 highest results < 150ml difference
Conclusions
Providing instant feedback to the patients on the In2itive e-Diary resulted in achieving higher repeatability for PEF and FEV1 data compared to the previous device. Further feedback messages could potentially help to provide even more reliable efficacy and safety data from home spirometry, as well as helping to bridge the gap between in-clinic spirometry results and home based measurements.
References
1. Harrison Aleck, Watson Elizabeth. Huff and puff; repeatability of serial home PEF & FEV1 recordings in a pharmaceutical trial. Eur Respir J 2010; 36: S54: E3967.
- © 2013 ERS