On-treatment adverse events experienced by ≥5% of patients in any treatment group (intent-to-treat population)
| Adverse event, n (%) | Placebo (N=20) | FF/VI 400/25 μg (N=40) |
| Any event | 10 (50) | 27 (68) |
| Nasopharyngitis | 3 (15) | 7 (18) |
| Headache | 1 (5) | 6 (15) |
| Dizziness | 1 (5) | 2 (5) |
| Oral candidiasis | 0 | 3 (8) |
| Dysphonia | 0 | 2 (5) |
| Chest pain | 1 (5) | 1 (3) |
| Dry mouth | 1 (5) | 0 |
| Dyspnoea | 1 (5) | 0 |
| ECG abnormal | 1 (5) | 0 |
| Erythema | 1 (5) | 0 |
| Hyperhidrosis | 1 (5) | 0 |
| Myalgia | 1 (5) | 0 |
| Fever | 1 (5) | 0 |
| Rash | 1 (5) | 0 |
| Urinary tract infection | 1 (5) | 0 |
FF, fluticasone furoate; VI, vilanterol.