An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD)

Ankit Kumar; Sandeepkumar Gupta; Punit K Jhawar; Suresh Raparthy; Satyajeet Sahoo; Sunil Kumar Raghumanda; Divya Bhojwani; Sagar Bhagat; Sumit Bhushan; Saiprasad Patil; Hanmant Barkate

doi:10.7759/cureus.104295

journal article Feb 26, 2026

An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD)

Sandeepkumar Gupta Punit K Jhawar Suresh Raparthy Satyajeet Sahoo Sunil Kumar Raghumanda Divya Bhojwani Sagar Bhagat Sumit Bhushan Saiprasad Patil Hanmant Barkate

Cureus · Springer Science and Business Media LLC

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References

23

[1]

Global Initiative for Asthma (GINA). World asthma day 2024. (2024). Accessed: February 26, 2026: https://ginasthma.org/world-asthma-day-2024/.

[2]

Global Asthma Network. The global asthma report 2025: patient stories. (2022). Accessed: February 26, 2026: https://globalasthmareport.org/.

[3]

Institute for Health Metrics and Evaluation. GBD 2019 diseases and injuries collaborators: GBD compare data visualization. (2022). Accessed: February 26, 2026: https://www.healthdata.org/data-tools-practices/interactive-visuals/gbd-compare.

[4]

Singh S, Salvi S, Mangal DK, et al.. Prevalence, time trends and treatment practices of asthma in India: the Global Asthma Network study. ERJ Open Res. 2022, 8:10.1183/23120541.00528-2021 10.1183/23120541.00528-2021

[5]

Global Initiative for Asthma. Global strategy for asthma management and prevention. (2024). Accessed: February 26, 2026: http://www.ginasthma.org.

[6]

Imam SF, Zafar S, Oppenheimer JJ. Single maintenance and reliever therapy in treatment of asthma exacerbations. Ann Allergy Asthma Immunol. 2022, 129:703-8. 10.1016/j.anai.2022.07.024 10.1016/j.anai.2022.07.024

[7]

Chapman KR. SMART isn't. J Allergy Clin Immunol. 2010, 125:609-10. 10.1016/j.jaci.2010.01.019 10.1016/j.jaci.2010.01.019

[8]

De Keyser H, Vuong V, Kaye L, et al.. Is once versus twice daily dosing better for adherence in asthma and chronic obstructive pulmonary disease?. J Allergy Clin Immunol Pract. 2023, 11:2087-2093.e3. 10.1016/j.jaip.2023.03.053 10.1016/j.jaip.2023.03.053

[9]

Albertson TE, Bullick SW, Schivo M, Sutter ME. Spotlight on fluticasone furoate/vilanterol trifenatate for the once-daily treatment of asthma: design, development and place in therapy. Drug Des Devel Ther. 2016, 10:4047-60. 10.2147/DDDT.S113573 10.2147/dddt.s113573

[10]

Central Drugs Standard Control Organization (CDSCO). Subject expert committee (SEC) proceedings. (2025). Accessed: February 26, 2026: https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/.

[11]

Aparici M, Gavaldà A, Ramos I, et al.. In vitro and in vivo preclinical profile of abediterol (LAS100977), an inhaled long-acting β2-adrenoceptor agonist, compared with indacaterol, olodaterol and vilanterol. Eur J Pharmacol. 2016, 770:61-9. 10.1016/j.ejphar.2015.11.053 10.1016/j.ejphar.2015.11.053

[12]

Global Imitative Asthma. 2022 GINA main report. (2022). Accessed: February 26, 2026: https://ginasthma.org/gina-reports/.

[13]

Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. New drugs and clinical trials rules. (2019). Accessed: December 24, 2025: https://www.cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTg4OA==.

[14]

World Medical Association. WMA Declaration of Helsinki - ethical principles for medical research involving human participants. (2025). Accessed: December 24, 2025: https://www.wma.net/policies-post/wma-declaration-of-helsinki/.

[15]

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline for good clinical practice. (2025). Accessed: February 26, 2026: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf.

[16]

Juniper EF, Bousquet J, Abetz L, Bateman ED. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006, 100:616-21. 10.1016/j.rmed.2005.08.012 10.1016/j.rmed.2005.08.012

[17]

Chapman KR, An L, Bosnic-Anticevich S, et al.. Asthma patients' and physicians' perspectives on the burden and management of asthma. Respir Med. 2021, 186:106524. 10.1016/j.rmed.2021.106524 10.1016/j.rmed.2021.106524

[18]

Jacques L, Bakerly ND, New JP, et al.. Effectiveness of fluticasone furoate/vilanterol versus fluticasone propionate/salmeterol on asthma control in the Salford lung study. J Asthma. 2019, 56:748-57. 10.1080/02770903.2018.1490751 10.1080/02770903.2018.1490751

[19]

Kumar A, Jain MK, Barge VB, et al.. Efficacy and safety of once-daily vilanterol/fluticasone furoate MDI in persistent asthma: phase 3 OD-INHALE study. J Asthma. 2024, 61:1181-9. 10.1080/02770903.2024.2330485 10.1080/02770903.2024.2330485

[20]

Lee LA, Bailes Z, Barnes N, et al.. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. Lancet Respir Med. 2021, 9:69-84. 10.1016/S2213-2600(20)30389-1 10.1016/s2213-2600(20)30389-1

[21]

Domingo C, Singh D. The changing asthma management landscape and need for appropriate SABA prescription. Adv Ther. 2023, 40:1301-16. 10.1007/s12325-022-02410-z 10.1007/s12325-022-02410-z

[22]

Averell CM, Stanford RH, Laliberté F, et al.. Medication adherence in patients with asthma using once-daily versus twice-daily ICS/LABAs. J Asthma. 2021, 58:102-11. 10.1080/02770903.2019.1663429 10.1080/02770903.2019.1663429

[23]

Agustí A, de Teresa L, De Backer W, et al.. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014, 43:763-72. 10.1183/09031936.00054213 10.1183/09031936.00054213

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Published: Feb 26, 2026

Authors

Sunil Kumar Raghumanda

Cite This Article

Ankit Kumar, Sandeepkumar Gupta, Punit K Jhawar, et al. (2026). An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD). Cureus. https://doi.org/10.7759/cureus.104295

An Open-Label, Single-Arm, Multicenter, Prospective, Post-Marketing Study to Evaluate the Effectiveness and Safety of Fluticasone Furoate/Vilanterol (FF/VI) Dry Powder Inhaler (DPI) in the Management of Asthma Patients (PROMISE-OD)

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