Related Experiment Video
Updated: Jan 10, 2026
Bronchial Thermoplasty: A Novel Therapeutic Approach to Severe Asthma
Published on: November 4, 2010
Evaluating the Real-world Effectiveness and Safety of Formoterol Fumarate and Fluticasone Propionate Combination in
Shital Patil1, Rajesh Venkitakrishnan2, Sarat K Behera3
1Pulmonologist, Department of Pulmonary Medicine, Venkatesh Chest Hospital and Critical Care Center, Latur, Maharashtra, India, Orcid: https://orcid.org/0000-0003-0502-5904.
Background:
India bears a significant burden of asthma, and asthma in India is characterized by high mortality rates. Poor adherence to treatment guidelines is observed. Several inhaled corticosteroid (ICS) with long-acting beta (β) 2 agonist (LABA) combinations are commercially marketed in India, formoterol fumarate-fluticasone propionate being one of them. Real-world Indian studies on fluticasone-formoterol from India are scarce. This study aims to evaluate the effectiveness and safety of formoterol fumarate (6 µg) and fluticasone propionate (250 µg) administered through a dry powder inhaler (DPI) or metered-dose inhaler (MDI) in Indian asthma patients.
Materials And Methods:
This 24-week prospective, multicenter study (CTRI/2023/08/056250) evaluated Formoflo 250 (formoterol fumarate 6 µg with fluticasone propionate 250 µg) transcaps (DPI), and Formoflo 250 transhaler (MDI) in adults aged 18-65 years. The primary endpoint was the mean change in trough forced expiratory volume in 1 second (FEV1) at week-24. Secondary endpoints included changes in trough forced vital capacity (FVC), asthma control test (ACT), and asthma quality of life questionnaire (AQLQ) scores. Safety was assessed through adverse events (AEs) and asthma exacerbations, with appropriate statistical analyses conducted on the modified intention-to-treat (mITT) population.
Results:
A total of 503 patients were enrolled, with 495 included in the mITT analysis and all 503 in the safety analysis. At week-24, a mean increase of 312.2 ± 121.1 mL was observed in trough FEV1, while trough FVC improved by 279.3 ± 147.3 mL (p < 0.0001). The mean ACT score increased by 11.6 ± 3.7 (p < 0.0001), while the mean AQLQ score improved by 2.5 ± 1.2 (p < 0.0001) at week-24. Adverse events were reported in 7.0% of patients, primarily mild, with no serious AEs or fatalities. The findings were consistent across both Formoflo DPI and MDI formulations.
Conclusion:
The combination of formoterol fumarate and fluticasone propionate significantly improved lung function, asthma control, and quality of life, demonstrating marked effectiveness and safety with both DPI and MDI in Indian asthma patients.
Related Concept Videos
01:25Antiasthma Drugs: β2-Adrenoceptor Agonists
One class of bronchodilators includes β2-adrenoceptor agonists. These agents target the β2-adrenoceptors located on bronchial smooth muscle cells. By stimulating these receptors, β2-agonists induce...
01:30Asthma-IV: Diagnostic and Management
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
01:25Antiasthma Drugs: Inhaled Corticosteroids and Glucocorticoids
ICS work through a multifaceted mechanism of action. They suppress the inflammatory response caused by the proliferation of TH cells. They also reduce the transcription of the IL-2 gene, which is involved in the...
01:19Antiasthma Drugs: Leukotriene Modifiers
Leukotriene modifiers work through two distinct mechanisms:
01:26COPD: Management Using Bronchodilators and Corticosteroids
01:23Inhaled Medications