# 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)

## TL;DR

A 12-week study found that the once-daily Indacaterol/Mometasone DPI is safe and effective for asthma patients, improving lung function and reducing symptoms.

## Contribution

This study provides real-world evidence of the safety and effectiveness of IND/MF DPI in Indian asthma patients.

## Key findings

- Only 14.37% of patients experienced mild to moderate adverse events with no serious events.
- Significant improvements in lung function (FEV1 and FVC) and asthma control (ACQ-5) were observed.
- Rescue medication use decreased, and 96.55% of patients reported treatment satisfaction.

## Abstract

What are the main findings?

The once-daily Indacaterol/Mometasone (IND/MF) DPI demonstrated a favorable safety profile over 12 weeks, with adverse events (AEs) reported in only 14.37% of patients, which were all mild to moderate in nature and not serious adverse events (SAEs);Significant improvements in lung function (trough FEV1 and FVC, p < 0.001), asthma control (ACQ-5, p < 0.001), reduced exacerbations, and lower rescue medication use were observed, and a majority of the patients and physicians were satisfied with the treatment.

The once-daily Indacaterol/Mometasone (IND/MF) DPI demonstrated a favorable safety profile over 12 weeks, with adverse events (AEs) reported in only 14.37% of patients, which were all mild to moderate in nature and not serious adverse events (SAEs);

Significant improvements in lung function (trough FEV1 and FVC, p < 0.001), asthma control (ACQ-5, p < 0.001), reduced exacerbations, and lower rescue medication use were observed, and a majority of the patients and physicians were satisfied with the treatment.

What does the primary finding suggest?

The absence of serious adverse events and the mild nature of reported AEs confirm the safety and tolerability of IND/MF DPI, making it suitable for long-term use in asthma management;IND/MF DPI can be a promising alternative for asthma management in patients inadequately managed with prior treatments, offering improved lung function, fewer exacerbations, and enhanced adherence, contributing to better disease management and enhanced quality of life.

The absence of serious adverse events and the mild nature of reported AEs confirm the safety and tolerability of IND/MF DPI, making it suitable for long-term use in asthma management;

IND/MF DPI can be a promising alternative for asthma management in patients inadequately managed with prior treatments, offering improved lung function, fewer exacerbations, and enhanced adherence, contributing to better disease management and enhanced quality of life.

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.