| Methods |
We have been unable to obtain confirmation that this study is the same trial as NCT00162773 (which is reported as randomised, but for which no data are reported). It is unclear from the trial report (a conference abstract) whether Creticos 2010 was randomised. It is hoped that this issue will be clarified by the next update of this review |
| Participants |
Eight participants in total, with five allocated to intervention and three to control. Details in conference abstract are very limited. Moderate to severe non‐allergic asthma |
| Interventions |
Omalizumab versus placebo |
| Outcomes |
Please see Notes below |
| Notes |
Conference abstract results and conclusions reported as: database/advertising screen of 870+ adult asthmatic patients yielded 85 participants (< 10%) meeting initial criteria, 29 of whom completed screening, with eight (1%) qualifying for enrolment. All participants had negative primary puncture skin test sensitivity/RASTs to perennial allergens (dust mite/cat/ dog/cockroach); two demonstrated secondary reactivity to dust mites. Mechanistically, an expected rise in serum IgE (1.5‐/6.4‐fold) was observed in two or four subjects four months taking omalizumab. DC and basophils from these participants showed a > 50% decrease in FceRIa. However, low serum IgE levels (<two of eight IU) were not increased in the other two omalizumab participants, nor were changes in FceRIa expression discernible. Placebo participants (n = 53) showed no drop in FceRIa. Finally, no discernible changes were observed in basophil/DC function in any of the omalizumab‐treated participants. Conclusions: This study demonstrates the difficulty in identifying a true subset of participants with the disease entity of NAA. Although expected shifts in cellular FceRIa expression were evident, we observed no evidence of clinical benefit (symptoms/lung function/med usage/QOL) in NAA participants treated with omalizumab |
