Table 3.
AES (>1 Subject in Any Treatment Group) and Any Airway Adverse Event
| Asthma subjects | COPD subjects | |||
|---|---|---|---|---|
| Adverse event, n (%) | Placebo (N=26) | Loxapine (N =26) | Placebo (N=27) | Loxapine (N=26) |
| No. (%) of subjects with any AE | 16 (61.5%) | 24 (92.3%) | 10 (37.0%) | 8 (30.8%) |
| Dysgeusia | 0 | 8 (30.8%) | 0 | 5 (19.2%) |
| Dizziness | 1 (3.8%) | 4 (15.4%) | 2 (7.4%) | 3 (11.5%) |
| Headache | 8 (30.8%) | 4 (15.4%) | 6 (22.2%) | 5 (19.2%) |
| Mental impairment | 0 | 2 (7.7%) | 0 | 0 |
| Sedation | 6 (23.1%) | 18 (69.2%) | 0 | 0 |
| Somnolence | 0 | 0 | 3 (11.1%) | 4 (15.4%) |
| Hyperhidrosis | 0 | 2 (7.7%) | 0 | 0 |
| No. (%) of subjects with any airway AE | 3 (11.5%) | 14 (53.8%) | 3 (11.1%) | 5 (19.2%) |
| Bronchospasm | 1 (3.8%) | 7 (26.9%) | 1 (3.7%) | 0 |
| Chest discomfort | 2 (7.7%) | 6 (23.1%) | 0 | 0 |
| Wheezing | 0 | 4 (15.4%) | 0 | 2 (7.7%) |
| Dyspnea | 0 | 3 (11.5%) | 1 (3.7%) | 3 (11.5%) |
| Cough | 0 | 1 (3.8%) | 0 | 3 (11.5%) |
| Throat tightness | 0 | 1 (3.8%) | 0 | 0 |
| Productive cough | 0 | 0 | 1 (3.7%) | 0 |
| Forced expiratory volume decreased | 0 | 1 (3.8%) | 0 | 1a (3.8%) |
All AEs presented were treatment emergent. Subjects with more than one occurrence of a specific AE are counted only once.
a
For one subject, the investigator reported a “greater than 20% drop in FEV1 from baseline” as an AE; there were no other airway AEs for this subject.