Clinical Data Hub

The evidence behind the Digihaler system

CONNECT1: The first study evaluating the Digihaler system vs SoC9

Assessing the impact of the Digihaler system on asthma management and level of asthma control9

As stated in the FDA-approved
Prescribing Information, there is no
evidence the use of the
Digihaler app
leads to improved clinical outcomes,
including safety and effectiveness.1

Study Design

CONNECT1 was a 12-week, open-label,
multicenter, parallel group study
consisting of 333 patients 13 years of
age
and older with asthma, with an ACT of
<19, who were receiving ICS and LABA,
using inhaled albuterol, and
were willing
to replace all other reliever medications
with ProAir® Digihaler® (albuterol sulfate).9

CONNECT1 study design
  • Improvement in asthma control defined as achievement of well-controlled asthma
    (ACT ≥20) and/or gaining a clinically meaningful improvement in ACT score of at least 3 units from baseline to Week 129
  • Differences in asthma management actions (interactions and interventions)9
  • Change in weekly average SABA use and weekly number of SABA-free days from baseline in the ProAir Digihaler system group9
  • Acceptability and usability of the ProAir
    Digihaler system utilizing the 10-question
    System Usability Scale9
  • Adverse events9
  • *Inhaler use is recorded as an event when the cap is opened or a patient inhales.

Abbreviation: SoC=standard of care

Objective data from the Digihaler system: Results of the secondary endpoints

The CONNECT1 study assessed the impact of the Digihaler system on SABA use, HCP-Patient
interactions, and the acceptability and usability of the Digihaler system

Reduction in mean weekly SABA use and increase in weekly number of
SABA-free days from baseline in the Digihaler system group at 12 weeks
Change in SABA use recorded over time by the Digihaler system9

Weekly Average SABA Use (n=135)

Weekly Average SABA Use chart

Weekly Number of SABA-Free Days (n=135)

Weekly SABA-Free Days chart

Higher number of HCP-Patient interactions with the Digihaler system versus Standard of Care

HCP-Patient interactions with the Digihaler system vs Standard of Care1,9

More HCP-reported interactions* due to poor inhaler technique in the Digihaler system group

More discussions* about inhaler technique and/or using† the inhaler as prescribed in the Digihaler system group

Fewer interactions* took place solely due to routine scheduling

*Interactions were defined as office visits or telephone calls. Interventions were defined as the content of discussions.

†Inhaler use is recorded as an event when the cap is opened or a patient inhales.

Assessment of the Digihaler system using the System Usability Scale14,15

The System Usability Scale consists of a 10-item questionnaire* and is a reliable tool for measuring usability.

Participants rated the app, and investigational sites rated the dashboard, as "Good" in terms of acceptability
and usability.

Usability Scale

*SUS consists of questions with 5 response options for respondents, from “strongly agree” to “strongly disagree.”

†The higher the number, the more favorable the usability.

‡Participants n=140, Sites n=27.

Adverse Events

The number of participants who had adverse events was similar across the 2 groups (28 in the ProAir Digihaler system group and 26 in the SoC group). No adverse events led to discontinuation or were considered device-related.9

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Important Safety Information:

AIRDUO® DIGIHALER® (fluticasone propionate and salmeterol) AND ARMONAIR® DIGIHALER® (fluticasone propionate)

  • 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
  • Serious Asthma-Related Events – Hospitalizations, Intubations, Death: Use of a LABA as monotherapy (without an ICS) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS (such as AirDuo Digihaler), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone
  • Deterioration of Disease and Acute Episodes: AirDuo Digihaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. ArmonAir Digihaler and AirDuo Digihaler are not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir Digihaler or AirDuo Digihaler, should be used to relieve acute symptoms such as shortness of breath
  • Avoid Excessive Use and Avoid Use with Other Long acting Beta2-Agonists: AirDuo Digihaler should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

    Patients using AirDuo Digihaler should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason

  • Oropharyngeal Candidiasis has occurred in patients treated with ArmonAir Digihaler or AirDuo Digihaler. Advise patients to rinse the mouth with water without swallowing following inhalation
  • Immunosuppression and Risks of Infections: Patients who use corticosteroids, such as found in AirDuo Digihaler and ArmonAir Digihaler are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections
  • Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. Taper patients slowly from systemic corticosteroids if transferring to ArmonAir Digihaler or AirDuo Digihaler
  • Hypercorticism and Adrenal Suppression may occur with high doses of ICS, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue ArmonAir Digihaler or AirDuo Digihaler slowly
  • Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with ArmonAir Digihaler or AirDuo Digihaler is not recommended because increased systemic corticosteroid adverse effects may occur; increased cardiovascular adverse effects may also occur with AirDuo Digihaler
  • Paradoxical Bronchospasm and Upper Airway Symptoms: Paradoxical bronchospasm may occur. If bronchospasm occurs treat immediately with an inhaled, short-acting bronchodilator discontinue AirDuo Digihaler or ArmonAir Digihaler and institute alternative therapy
  • Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir Digihaler or AirDuo Digihaler. Discontinue ArmonAir Digihaler or AirDuo Digihaler if such reactions occur
  • Cardiovascular and Central Nervous System Effects: The salmeterol component of AirDuo Digihaler, can be associated with excessive beta-adrenergic stimulation which could present as the following symptoms: seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Use with caution in patients with cardiac arrhythmias, hypertension, coronary insufficiency. Drug may need to be discontinued in certain patients.
  • Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care when using ArmonAir Digihaler or AirDuo Digihaler
  • Effect on Growth: ICS may cause a reduction in growth velocity, Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients receiving ArmonAir Digihaler and AirDuo Digihaler.
  • Glaucoma and Cataracts: Long-term use of ICS, including fluticasone propionate, a component of ArmonAir Digihaler and AirDuo Digihaler, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered
  • Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur when using ArmonAir Digihaler or AirDuo Digihaler. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy
  • Coexisting Conditions: Use AirDuo Digihaler with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines
  • Hypokalemia and Hyperglycemia: Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. Decrease in serum potassium are usually transient, not requiring supplementation. Be alert to hypokalemia and hyperglycemia in patients using AirDuo Digihaler
  • Adverse Reactions with ArmonAir Digihaler: Most common adverse reactions (greater than or equal to 3%) are: upper respiratory tract infection, nasopharyngitis, oral candidiasis, headache, and cough
  • Adverse Reactions with AirDuo Digihaler: Most common adverse reactions (greater than or equal to 3%) include nasopharyngitis, oral candidiasis, headache, cough and back pain

INDICATIONS FOR AIRDUO AND ARMONAIR DIGIHALER

ArmonAir Digihaler 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 inhalation powder is 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.

ArmonAir Digihaler and AirDuo Digihaler contain a built-in electronic module which detects, records, and stores data on inhaler events for transmission to mobile App. Use of the App is not required for administration of medication to the patient.

Please see full Prescribing Information for ArmonAir Digihaler and AirDuo Digihaler.

Important Safety Information:

PROAIR® DIGIHALER® (albuterol sulfate)

  • Contraindications: ProAir Digihaler Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
  • Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs
  • Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids
  • Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
  • Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
  • Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
  • Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler.
  • Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines.
  • Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation
  • Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting
  • Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler
    • Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
    • Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
    • Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
    • Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy

INDICATION FOR PROAIR DIGIHALER

ProAir Digihaler Inhalation Powder is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and in patients 4 years of age and older for the prevention of exercise-induced bronchospasm.

ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile app. Use of the mobile app is not required for administration of medication to the patient.

Please see full Prescribing Information for ProAir Digihaler.

Devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) These devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Teva could void the user's authority to operate the equipment.

References: 1. ProAir Digihaler. Prescribing Information. Teva; 2022. Accessed July 1, 2022. https://www.digihalerhcp.com/globalassets/
proair_digihaler/
proair_digihaler_pi.pdf 2. AirDuo Digihaler. Prescribing information. Teva; 2022. Accessed July 1, 2022. https://
www.digihalerhcp.com/globalassets/
airduo_digihaler/airduo_digihaler_pi.pdf 3. ArmonAir Digihaler. Prescribing Information. Teva; 2022. Accessed July 1, 2022. https://
www.digihalerhcp.com/
globalassets/
armonair_digihaler/armonair_digihaler_pi.pdf 4. Sulaiman I, Seheult J, MacHale E, et al. Irregular and ineffective: a quantitative observational study of the time and technique of inhaler use. J Allergy Clin Immunol Pract. 2016;4(5):900-909. 5. Patel M, Perrin K, Pritchard A, et al. Accuracy of patient self-report as a measure of inhaled asthma medication use. Respirology. 2013;18(3):546-552. 6. Unni E, Gabriel S, Ariely R. A review of the use and effectiveness of digital health technologies in patients with asthma. Ann Allergy Asthma Immunol. 2018;121(6):680-691. 7. Silver HS, Blanchette CM, Kamble S, et al. Quarterly assessment of short-acting beta(2)-adrenergic agonist use as a predictor of subsequent health care use for asthmatic patients in the United States. J Asthma. 2010;47(6):660-666. 8. Azzi EA, Kritikos V, Peters MJ, et al. Understanding reliever overuse in patients purchasing over-the-counter short-acting beta2 agonists: an Australian community pharmacy-based survey. BMJ Open. 2019;9(8):e028995. 9. Hoyte FCL, Mosnaim GS, Rogers L, et al. Effectiveness of a digital inhaler system for patients with asthma: a 12-week, open-label, randomized study (CONNECT1). J Allergy Clin Immunol Pract. 2022;10(10):2579-2587. 10. Advair Diskus Prescribing Information. GSK; 2020. Accessed September 13 2022. https://gskpro.com/
content/dam/global/hcpportal/en_US/
Prescribing_Information/
Advair_Diskus/pdf/
ADVAIR-DISKUS-PI-PIL-IFU.PDF 11. Flovent HFA Prescribing Information. GSK; 2022. Accessed September 13, 2022. https://gskpro.com/
content/
dam/global/hcpportal/en_US/
Prescribing_Information/Flovent_HFA/pdf/
FLOVENT-HFA-PI-PIL-IFU.PDF 12. Flovent Diskus Prescribing Information. GSK; 2022. Accessed September 13, 2022. https://gskpro.com/
content/dam/global/hcpportal/en_US/
Prescribing_Information/Flovent_Diskus/pdf/
FLOVENT-DISKUS-PI-
PIL-IFU.PDF 13. Melani AS, Bonavia M, Cilenti V, et al. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011;105(6):930-938. 14. Data on File. Frazer, PA: Teva Respiratory, LLC. 15. Brooke J. SUS: a “quick and dirty” usability scale. In Jordan PW, Thomas B, Weerdmeester BA, McClelland IL, eds. Usability Evaluation in Industry. Taylor & Francis Ltd; 1996:189-194.

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Due to technical changes in Google policies, the Digihaler app was temporarily removed from the Google Play Store.

We are working on an update and will publish a new version soon. If you would like more information or a notification when the app is available again, please call our team at 888-603-0788.

Note: This does not affect the Apple App Store.

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