mprovement inFEV1 over the pre-treatment value than the matched placebo.
In this study, 48 of 92 patients treated with albuterol sulfate MDPI achieved a 15% increase in FEV1 within 30 minutespost-dose on Day 1. The median time to onset was 5.9 minutes, and the median duration of effect as measured by a 15%increase was approximately 1 hour.
In a placebo-controlled, single-dose, crossover study in 61 patients 4 to 11 years of age, albuterol sulfate MDPI,administered at albuterol doses of 90 and 180 mcg, was compared with a matched placebo and with albuterol HFA MDI.
Albuterol sulfate MDPI provided similar bronchodilation when administered as one or two inhalations (baseline-adjustedpercent-predicted serial FEV1 observed over 6 hours post-dose), whereas two inhalations from albuterol HFA MDIprovided significantly greater bronchodilation compared to a single inhalation.
14.3 Exercise-Induced Bronchospasm
In a randomized, single-dose, crossover study in 38 adult and adolescent patients with exercise-induced bronchospasm(EIB), two inhalations of albuterol sulfate MDPI taken 30 minutes before exercise prevented EIB for the hour followingexercise (defined as the maintenance of FEV1 within 80% of post-dose, pre-exercise baseline values) in 97% (37 of 38) ofpatients as compared to 42% (16 of 38) of patients when they received placebo.
Patients who participated in these clinical trials were allowed to use concomitant steroid therapy.
16 HOW SUPPLIED/STORAGE AND HANDLING
ProAir Digihaler (NDC 59310-117-20) inhalation powder is supplied as a white dry powder inhaler with a red cap sealedin a foil pouch in boxes of one. Each inhaler contains 0.65g of the formulation and provides 200 actuations.
Store at room temperature (between 15° and 25°C; 59° and 77°F). Avoid exposure to extreme heat, cold, or humidity.
Keep out of reach of children.
ProAir Digihaler inhaler has a dose counter. Patients should never try to alter the numbers for the dose counter. Discardthe inhaler 13 months after opening the foil pouch, when the counter displays 0, or after the expiration date on theproduct, whichever comes first. 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 CounselingInformation (17)].
ProAir Digihaler contains a QR code and a built-in electronic module which automatically detects, records, and storesdata on inhaler events, including peak inspiratory flow rate (L/min). ProAir Digihaler may pair with and transmit data tothe mobile App via Bluetooth® wireless technology where inhaler events are categorized.
ProAir Digihaler contains a lithium-manganese dioxide battery and should be disposed of in accordance with state andlocal regulations.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Patientsshould be given the following information:
Frequency of Use
The action of ProAir Digihaler should last for 4 to 6 hours. Instruct patients to not use ProAir Digihaler more frequentlythan recommended. Instruct patients to not increase the dose or frequency of doses of ProAir Digihaler without consultingthe physician. If patients find that treatment with ProAir Digihaler becomes less effective for symptomatic relief,symptoms become worse, and/or they need to use the product more frequently than usua |
