
The AirDuo Digihaler may help you
Review quality of inhalations and detect missed doses2*†
Indicated for the treatment of asthma in patients 12 years of age 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.
Contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures. Contraindicated in patients with known severe hypersensitivity to milk proteins or any ingredients of AirDuo Digihaler.
Please see additional Important Safety Information in the scroll below.
*As measured by inspiratory flow.
†Inhaler use is recorded as an event when a patient opens the cap or inhales.

See the Data
AirDuo Digihaler
- Dosing
- Features
- Efficacy
- Adverse Events
AirDuo Digihaler has the lowest approved dose of fluticasone propionate and salmeterol at each strength2,10
AirDuo Digihaler | Advair Diskus® | ||||
Dosage | Fluticasone Propionate | Salmeterol | Fluticasone Propionate | Salmeterol | |
Low | 55 mcg | 14 mcg | 100 mcg | 50 mcg | |
Medium | 113 mcg | 14 mcg | 250 mcg | 50 mcg | |
High | 232 mcg | 14 mcg | 500 mcg | 50 mcg |
Advair Diskus® is a registered trademark of the GSK group of companies
AirDuo Digihaler should be given2:
- 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
AirDuo Digihaler vs nondigital counterpart
Features | AirDuo® Digihaler® | AirDuo RespiClick® |
Efficacy and safety2 | Digihaler inhalers and their nondigital counterparts share the same efficacy and safety profile* | |
Tracks and categorizes quality of inhalations2 | ||
Measures inspiratory flow rates2 | ||
Tracks how often the inhaler is used2,4,5 | ||
Captures patterns of maintenance inhaler use and missed doses2,4,5 | ||
Connects to a companion mobile app for viewing inhaler use data2 |
Inhaler use is recorded as an event when
a cap is opened or a patient inhales.
* The Digihaler products were approved based on the safety and efficacy data from their nondigital counterparts.
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.
The safety of AirDuo Digihaler has been established from adequate and well-controlled studies of fluticasone propionate and salmeterol MDPI. There is no evidence that the use of the Digihaler app leads to improved clinical outcomes, including safety and effectiveness.
Improvements in lung function in clinical trials2
Fluticasone propionate 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).
Fluticasone propionate MDPI demonstrated significantly greater FEV1 improvement vs placebo across all dosage strengths.
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; ICS=inhaled corticosteroid; LABA=long-
acting beta2-agonist; MDPI=multidose dry powder inhaler
Early onset of action and sustained efficacy in a clinical trials program2
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.
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 both fluticasone propionate/salmeterol MDPI dose groups.
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 profile2
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
were more common than placebo in subjects with asthma in trials 1 and 2
Flucticasone propionate and salmeterol MDPI | ||||
Adverse Reaction | 55/14 mcg (n=128) % |
113/14 mcg (n=269) % |
232/14 mcg (n=145) % |
Placebo (n=273) % |
8.6 | 4.8 | 6.9 | 4.4 | |
Oral candidiasis* | 1.6 | 2.2 | 3.4 | 0.7 |
Back pain | 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.
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.