AIRDUO® DIGIHALER® (fluticasone
propionate and salmeterol)
inhalation powder
Asthma control
with less medicine


Events
AirDuo Digihaler has the lowest approved dose of fluticasone propionate and salmeterol at each strength2
AIRDUO® DIGIHALER®
FLUTICASONE PROPRIONATE
*
SALMETEROL
Low
55 mcg
*
14 mcg
Medium
113 mcg
*
14 mcg
High
232 mcg
*
14 mcg
ADVAIR DISKUS®2
FLUTICASONE PROPRIONATE
*
SALMETEROL
Low
100 mcg
*
50 mcg
Medium
250 mcg
*
50 mcg
High
500 mcg
*
50 mcg
Advair Diskus ® is a registered trademark of the GSK group of companies
AirDuo Digihaler should be given:
- As 1 inhalation twice daily about 12 hours apart
- By oral inhalation only
Table is intended to show differences in dosing only and should not be construed to imply safety or efficacy similarities or differences
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR ARMONAIR DIGIHALER AND AIRDUO DIGIHALER
INDICATIONS
ArmonAir® Digihaler® (fluticasone propionate) inhalation powder is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older. Limitation of Use: ArmonAir Digihaler is not indicated for the relief of acute bronchospasm.AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo Digihaler is only for patients uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants an ICS/Long-acting beta2-agonist (LABA).Limitation of Use: AirDuo Digihaler is not indicated for the relief of acute bronchospasm.
important safety information
-
Contraindications: ArmonAir Digihaler and AirDuo Digihaler are contraindicated in:
-
Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
-
Patients with known severe hypersensitivity to milk proteins or any ingredients of ArmonAir Digihaler or AirDuo Digihaler READ MORE
AirDuo Digihaler is the first breath-actuated, digital ICS/LABA inhaler
Inhaler use is recorded as an event when the cap is opened or a patient inhales.
See how AirDuo Digihaler compares to:
Features
Contains a built-in dose counter
Measures inspiratory flow rates
Tracks how often the inhaler is used
Connects to a companion mobile app for viewing inhaler use
Requires no hand-breath coordination during inhalation1
AirDuo®
Digihaler®
Abbreviations: BAI=breath-actuated inhaler; DPI=dry-powder inhaler; ICS=inhaled corticosteroid; LABA=long-acting beta agonist;
MDI= metered-dose inhaler
Product characteristics listed are not all-inclusive and cannot be used to infer product efficacy or safety
Connection to the app is required for transmission of data but is not required for delivery of the medicine from the inhaler. There is no evidence the use of Digihaler technology alone leads to improved clinical outcomes, including safety and effectiveness.
The safety of AirDuo Digihaler has been established from adequate and well-controlled studies of fluticasone propionate and salmeterol MDPI.
Improvements in lung function in clinical trials
Fluticasone propionate and salmeterol MDPI demonstrated significantly greater FEV1 improvement vs placebo across all dosage strengths.
Trial 1: Mean change from baseline in trough FEV1 at each visit by treatment group (FAS)


Trial 1 Design: This randomized, double-blind, placebo-controlled, 12-week, global efficacy and safety trial compared fluticasone propionate and salmeterol MDPI 55/14 mcg and 113/14 mcg (1 inhalation twice daily) and placebo in adolescent and adult patients with persistent symptomatic asthma despite low-dose or mid-dose ICS or ICS/LABA therapy. Additional arms in this study received fluticasone propionate MDPI 55 mcg and 113 mcg (1 inhalation twice daily).
Abbreviations: FAS=full analysis set; FEV1= forced expiratory volume in 1 second; MDPI=multidose dry powder inhaler
Trial 2: Mean change from baseline in trough FEV1 at each visit by treatment group (FAS)


Trial 2 Design: This randomized, double-blind, placebo-controlled, 12-week, global efficacy and safety trial compared fluticasone propionate and salmeterol MDPI 113/14 mcg and 232/14 mcg (1 inhalation twice daily) and placebo in adolescent and adult patients with persistent symptomatic asthma despite ICS or ICS/LABA therapy. Additional arms in this study received fluticasone propionate MDPI 113 mcg and 232 mcg (1 inhalation twice daily).
Abbreviations: FAS=full analysis set; FEV1= forced expiratory volume in 1 second; MDPI=multidose dry powder inhaler
Early onset of action and sustained efficacy in a clinical trials program
Fluticasone propionate and salmeterol MDPI demonstrated improvement in lung function within 15 minutes of the first dose across all dosage strengths. Maximum improvement in FEV1 generally occurred within 3 hours for fluticasone propionate/salmeterol MDPI 55/14 mcg and within 6 hours for fluticasone propionate/salmeterol MDPI 113/14 mcg.
Trial 1: Serial spirometry—Mean change from baseline in FEV1 at Day 1 by
time point and treatment group (FAS; serial spirometry subset)


Trials 1 and 2: The primary endpoints for these trials were the changes from baseline in trough FEV1 at
week 12 for all patients and standardized baseline-adjusted FEV1 AUEC0-12h at week 12 analyzed for a
subset of 312 patients who performed post dose serial spirometry.
Abbreviation: AUEC0-12h=area under effect-time curve 0-12 hours
Trial 2: Serial spirometry—Mean change from baseline FEV1 at Day 1 by time point and treatment group (FAS; serial spirometry subset)


Trials 1 and 2: The primary endpoints for these trials were the changes from baseline in trough FEV1 at week 12 for all patients and standardized baseline-adjusted FEV1 AUEC0-12h at week 12 analyzed for a subset of 312 patients who performed post dose serial spirometry.
Abbreviation: AUEC0-12h=area under effect-time curve 0-12 hours
Safety profile
The safety of fluticasone propionate and salmeterol MDPI was evaluated in patients with asthma who were previously treated with an ICS.
Adverse reactions with ≥3% incidence with fluticasone propionate and salmeterol MDPI, and more common than placebo in subjects with asthma in trials 1 and 2
ADVERSE REACTION
Flucticasone propionate and salmeterol MDPI 55/14 mcg (n=128) %
Flucticasone propionate and salmeterol MDPI 113/14 mcg (n=269) %
Flucticasone propionate and salmeterol MDPI 232/14 mcg (n=145) %
Placebo (n=273) %
Nasopharyngitis
8.6
4.8
6.9
4.4
Oral candidiasis*
1.6
2.2
3.4
0.7
Backpain
3.1
0.7
0.0
1.8
Headache
5.5
4.8
2.8
4.4
Cough
2.3
3.7
0.7
2.6
*Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, and oropharyngitis fungal.
MDPI=metered dry powder inhaler
In a long-term, open-labeled safety study, the types of adverse reactions were similar to those reported above in the placebo-controlled studies. The 26-week safety study included 674 patients previously treated with ICS who were treated twice daily with fluticasone propionate MDPI 113 mcg or 232 mcg; fluticasone propionate/salmeterol MDPI 113/14 mcg or 232/14 mcg; fluticasone propionate inhalation aerosol 110 mcg or 220 mcg; fluticasone propionate and salmeterol inhalation powder (250/50 mcg), or fluticasone propionate and salmeterol inhalation powder (500/50 mcg), the types of adverse reactions were similar to those reported above in placebo-controlled study.