Prospective, Open-Label, Observational, Multicenter, Single Arm, Post-Marketing Study in Asthmatic Patients for Evaluation of Safety and Effectiveness of Indacaterol/Mometasone DPI (PROMISING-SHIFT)

Abstract

Background: Asthma significantly impacts global health, necessitating effective management strategies. A combination of inhaled corticosteroids (ICSs) and long-acting β2-agonists (LABA) is recommended for patients with inadequately controlled asthma.

Method: This prospective, open-label, multicenter study (PROMISING-SHIFT) study evaluated the safety and efficacy of once-daily Indacaterol/Mometasone (IND/MF) dry powder inhaler (DPI) in Indian asthma patients (≥12 years), inadequately controlled with prior therapies. Patients received IND/MF DPI in three strengths (150/80 mcg, 150/160 mcg, 150/320 mcg) over 12 weeks.

Results: The study included a total of 174 participants, and 27 adverse events (AEs) in 25 patients (14.37%) were reported, primarily mild to moderate, with no serious adverse events (SAEs). Drug-related treatment-emergent adverse events (TEAEs) were observed in 11 patients. Significant improvements were noted in the mean trough FEV1 and FVC, increasing from baseline to week 4 and week 12 (p < 0.001). The mean ACQ-5 score significantly decreased from 3.0 ± 0.73 baseline to 2.50 ± 0.53 (16.67%) at week 4 and further to 1.73 ± 0.35 at week 12, along with reduced exacerbations (p < 0.001). The need for rescue medication declined from 13.79% to 8.62%, and 96.55% of patients reported treatment satisfaction by study completion.

Conclusion: Once-daily IND/MF DPI demonstrated a favorable safety profile with marked improvements in lung function, asthma control, and patient satisfaction, making it a promising option for long-term asthma management in Indian patients.

Keywords: Indacaterol/Mometasone; LABA; asthma; inhaled corticosteroids.

Figure 1

Flowchart of patients in the study.

Figure 2

Improvements in mean trough FEV1 throughout the 12-week treatment period. (A) Mean trough FEV1 at baseline; week 4 and week 12 of treatment. (B) Mean change in trough FEV1 from baseline to week 4, week 4 to week 12, and from baseline to week 12.

Figure 3

Improvements in mean trough FVC throughout the 12-week treatment period. (A) Mean trough FVC at baseline; week 4 and week 12 of treatment. (B) Mean change in trough FVC from baseline to week 4, week 4 to week 12, and from baseline to week 12.

Figure 4

Reduction in mean ACQ-5 scores during the treatment period. (A) Mean ACQ-5 score at baseline, week 4, and week 12 of treatment. (B) Change in mean ACQ-5 score from baseline to week 4, week 4 to week 12, and from baseline to week 12.

Figure 5

Patient satisfaction with asthma treatment over 12 weeks. (A) Do you find it easy to fit your asthma medication into your everyday life? (B) When you take your medication, do you feel confident that your asthma symptoms will be controlled? (C) Do you worry that you are not taking the right medication for your asthma symptoms? (D) Do you find it easy to carry your asthma inhaler(s) with you, and do not have any taste or smell complaints? (E). Do you feel confident in using your inhaler(s)?

Figure 6

Physician’s satisfaction with asthma treatment over 12 weeks. (A) Do you feel that patient’s asthma medication fits into their everyday life? (B) Do you feel confident in the ability of this medication to control patient’s asthma symptoms? (C) Do you have any worries or uncertainties about whether this is the appropriate medication for this patient? (D) Do you feel it is convenient for the patient to carry their asthma inhaler with them and not have any taste or smell complaints? (E) Does the patient demonstrate confidence in their ability to use their inhaler(s) effectively?