Table 4.
(a) Breezhaler checklist | Day 1 | Day 7 | (b) HandiHaler checklist | Day 1 | Day 7 |
---|---|---|---|---|---|
1. Pull off cap | 100.0 | 100.0 | 1. Open the cap | 98.8 | 97.5 |
2. Open mouthpiece | 98.8 | 100.0 | 2. Open mouthpiece | 96.3 | 97.5 |
3. Remove capsule from blister pack | 98.8 | 100.0 | 3. Remove capsule from blister pack | 93.8 | 97.5 |
4. Insert capsule in the inhaler | 100.0 | 100.0 | 4. Insert capsule in the inhaler | 98.8 | 100.0 |
5. Close inhaler – click heard | 98.8 | 98.8 | 5. Close inhaler – click heard | 98.8 | 98.8 |
6. Pierce the capsule | 95.1 | 98.8 | |||
6. Was the mouthpiece facing upwards? | 96.3 | 97.5 | 7. Pierced once only | 92.7 | 91.4 |
7. Pierce the capsule | 97.5 | 96.3 | 8. Click/piercing noise heard by assessor | 92.7 | 100.0 |
8. Pierced once only | 95.1 | 90.0 | 9. Was inhaler held upright? | 89.0 | 88.9 |
9. Click/piercing noise heard | 93.8 | 95.0 | |||
10. Were both buttons pressed simultaneously? | 95.1 | 97.5 | |||
11. Release buttons | 90.2 | 97.5 | 10. Release button | 88.9 | 96.3 |
12. Were buttons fully released before inhalation?a | 92.7 | 96.3 | 11. Was button fully released before inhalation?a | 87.7 | 98.8 |
13. Breathe out – not into mouthpiecea | 84.1 | 85.2 | 12. Breathe out – not into mouthpiecea | 80.2 | 81.3 |
13. Was inhaler held horizontally during inhalation? | 85.2 | 95.0 | |||
14. Inhale the medicine rapidly and steadily | 87.8 | 93.8 | 14. Inhale the medicine slowly and deeply | 88.9 | 93.8 |
15. Were the air inlets unobstructed by fingers? | 92.7 | 91.4 | 15. Were the air inlets unobstructed by fingers? | 91.4 | 95.0 |
16. Audible whirring noise | 82.9 | 91.4 | |||
17. Hold breath for as long as is comfortable | 84.1 | 77.8 | 16. Hold breath for as long as is comfortable | 75.3 | 86.3 |
18. Check upon whether capsule has been fully emptied | 80.5 | 77.8 | |||
19. If residue is remaining in capsule, did patient close inhaler and repeat steps 13–18 | 82.1 | 80.8 | 17. Did the patient repeat steps 12–16 to ensure full dose was taken from capsule? | 69.1 | 83.8 |
20. Open inhaler, remove capsule, close inhaler and replace cap | 95.1 | 96.3 | 18. Open cap, remove capsule, close and replace cap | 88.9 | 97.5 |
21. Was capsule pierced at both ends? | 93.9 | 98.8 | 19. Was capsule pierced at both ends? | 95.1 | 96.3 |
Note: Prespecified as a particularly critical step.