“…Previous studies of allergen challenges of either grass pollen or HDM show that symptom scores rise over the first 1â2 h and are followed by a plateau phase. The plateau phase indicates that the symptom scores have stabilized, and was therefore considered the more relevant time to analyse the primary outcome . - Along with the evaluation period, the calculation of the effect size (e.g., mean and/or AUC) should be reported and justified in the study protocol prior to performance of the study and data analysis.
- Chamberâspecific placebo (development of symptoms in sensitized patients exposed to allergenâfree air, the soâcalled âsham runâ) and nocebo (development of symptoms due to just seeing chamber subjects with exacerbation of allergic symptoms) effects should be documented as it increases the validity of the exposure tests.
- Safety measures should be specified in terms of:
- Selection of subjects suitable for exposure,
- Prevention of adverse reactions (e.g., by monitoring symptoms and lung function in asthmatic patients),
- Availability of emergency medical personnel and resuscitation equipment,
- Availability of nearby emergency room and intensive care facilities,
- Definition of surveillance procedure following exposure (e.g., lateâphase asthmatic reaction),
- Reporting of all adverse events and their treatment.
…”