Table 1.
Success Criteria for Inhub and Diskus Inhaler Tasks for Study 1
| Task | Inhaler | Script printed on task card | Purpose of task | Criteria assesseda |
|---|---|---|---|---|
| 1 | Inhub |
Current Advair Diskus subjects only: “You have been using Advair for a number of years. However, during your last visit to the pharmacy, you were given this inhaler as a generic alternative. The medication and dose frequency are exactly the same as they were with Advair; 1 dose twice a day, morning and evening. The only difference is the inhaler. This is now your first day of using the inhaler. Prepare to take the medication and take a dose.” Asthma and/or COPD subjects naïve to all dry powder inhalers “You have been using a metered dose inhaler for a number of years. However, the doctor has just prescribed a dry powder inhaler which is designed to control your asthma. You will take the medication twice a day, once in the morning and once in the evening. You took the prescription to the pharmacy and were given this inhaler. This is your first day of using the inhaler. Prepare to take the medication and take a dose.” |
Assess the intuitiveness and first use of the inhaler | 1–2, 3i, and 4–6 |
| 2 | Inhub | “You are now due to take your next dose using the same inhaler. Prepare to take the medication and take your next dose.” | Show any improvement in technique | 1–2, 3i, and 4–6 |
| 3 | Inhub | “You are now due to take your next dose using the same inhaler. Prepare to take the medication and take your next dose.” | Demonstrate “at-home use” | 1–2, 3i, and 4–6 |
| Any subject who holds the Inhub inhaler horizontally for the inhalation step in any of the first 3 tasks will now be asked to demonstrate his or her inhalation horizontally through an instrumented Inhub inhaler, and his or her inhalation profile will be recorded. | 3ii | |||
| 4 | Diskus |
Current Advair Diskus subjects only: “Please take a dose (using this inhaler) as you would do normally with your Advair Diskus.” |
Demonstrate any pre-learned misuse behaviors with the Advair Diskus | 1–6 |
| 5 | Diskus |
Current Advair Diskus subjects only: “Please take another dose (using this inhaler) as you would do normally with your Advair Diskus.” |
Confirm any pre-learned misuse behaviors from their use of Advair Diskus | 1–6 |
| 6 | Diskus |
Current Advair Diskus subjects only: “Please take another dose (using this inhaler) as you would do normally with your Advair Diskus.” |
Confirm any pre-learned misuse behaviors from their use of Advair Diskus | 1–6 |
a
Criteria: (1) Subject can open the mouthpiece cover; (2) Subject pushes the lever as far as it will go; (3i) Subject holds the inhaler in the vertical orientation – OR – (3ii) If the subject holds in the horizontal orientation, inhaled flow rates of ≥30 L/min and inhaled volumes of ≥1 L are achieved; (4) Subject leaves the lever fully pushed during inhalation; (5) Subject fully closes the mouthpiece cover for storage; and (6) Subject is not injured during use of the inhaler.