he
improvement was sustained over the 12 weeks of treatment in the trial. No diminution in the 12
hour bronchodilator effect was observed with either fluticasone propionate/salmeterol MDPIdose as assessed by FEV1 following 12 weeks of therapy.
Figure 7: Serial Spirometry: Mean Change from Baseline in FEV1 (L) at Day 1 by TimePoint and Treatment Group Trial 2 (FAS; Serial Spirometry Subset)
FS MDPI = fluticasone propionate/salmeterol multidose dry powder inhaler: FP MDPI = fluticasone propionatemultidose dry powder inhaler; FAS = full analysis set; FEV1 = forced expiratory volume in 1 second
Figure 8: Serial Spirometry: Mean Change from Baseline in FEV1 (L) at Week 12 by TimePoint and Treatment Group Trial 2 (FAS; Serial Spirometry Subset)
FS MDPI = fluticasone propionate/salmeterol multidose dry powder inhaler: FP MDPI = fluticasone propionate
multidose dry powder inhaler; FAS = full analysis set; FEV1 = forced expiratory volume in 1 second
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
AirDuo Digihaler is supplied in the following three strengths as a white multidose dry-powder
inhaler (MDPI) with an electronic module. Each inhaler has a yellow cap and is packaged
individually in a foil pouch in a carton. Each inhaler contains 0.45grams of the formulation and
provides 60 actuations:
STRENGTH NDC CODE
AirDuo Digihaler 55/14 mcg (low) NDC 59310-111-06
AirDuo Digihaler 113/14 mcg (medium) NDC 59310-129-06
AirDuo Digihaler 232/14 mcg (high) NDC 59310-136-06
Each AirDuo Digihaler inhaler has a dose counter attached to the actuator. Patients should nevertry to alter the numbers for the dose counter. Discard the inhaler when the counter displays 0, 30days after opening the foil pouch or after the expiration date on the product, whichever comesfirst. The labeled amount of medication in each actuation cannot be assured after the counterdisplays 0, even though the inhaler is not completely empty and will continue to operate [see
Patient Counseling Information (17)].
16.2 Storage and Handling
Store at room temperature (between 15º and 25ºC; 59º and 77ºF) in a dry place; excursionspermitted from 59º F to 86º F (15ºC to 30ºC). Avoid exposure to extreme heat, cold, or humidity.
Store AirDuo Digihaler inside the unopened, moisture-protective foil pouch until initial use.
Discard AirDuo Digihaler 30 days after opening the foil pouch or when the counter reads 0,whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
AirDuo Digihaler includes a QR code, and contains a built-in electronic module whichautomatically detects, records, and stores data on inhaler events, including peak inspiratory flowrate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App viaBluetooth® wireless technology where inhaler events are categorized.
AirDuo Digihaler contains a lithium-manganese dioxide battery and should be disposed of inaccordance with state and local regulations.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information andInstructions for Use).
Patients should be given the following information:
Serious Asthma Events
Inform patients with asthma that LABA when used alone increases the risk of asthma-relatedhospitalization and asthma-related death. Available data show that when ICS and LABA areused together, such |
