Comparative Evaluation of Fixed Dose Combinations of Fluticasone/ Formoterol and Budesonide/ Formoterol in Patients of Mild- Moderate Bronchial Asthma

Authors:

Kaushal S^1*, Singh J², Kajal NC³ and Biswas A⁴

Volume 1, Issue 2

Abstract

The prevalence of asthma is rising worldwide with 10–12% adults and 15% children affected presently. It can have a considerable impact on the quality of life of both, patients and their caregivers. Fixed dose combination of Inhaled corticosteroids (ICS) like fluticasone and budesonide and long acting beta 2 agonists (LABAs) in the form of metered dose inhaler (MDI) are synergistic in action and provide effective control in asthma.

Objectives: In the present study, two ICS & LABA combinations i.e. fluticasone/ formoterol and budesonide/ formoterol were compared, both administered through a metered dose inhaler (MDI) with a spacer, for achieving and maintaining asthma control, improving symptoms, pulmonary function tests and quality of life in patients of mild to moderate bronchial asthma.

Methods: It was a prospective, open- label, randomized, parallel study conducted for a total duration of 12 weeks. The parameters used to compare the two MDIs at 0, 6 and 12 weeks were:

a. Pulmonary function tests – FEV1, PEFR

b. Asthma control scoring (according to the GINA definition of control)

c. Standardized Asthma Quality of Life Questionnaire [AQLQ(S)]

d. Adverse effect profile

Results: By the end of 12 weeks, asthma control was similarly achieved among the two groups except that fluticasone/ formoterol was significantly better than budesonide/ formoterol in reducing the need for rescue bronchodilator use (p= 0.000) and in improving daytime symptoms at 6 weeks (p=0.000). Fluticasone/ formoterol at 6 weeks, significantly increased the percent predicted PEFR (p= 0.007) and percent improvement in AQLQ(S) score (p=0.006) in comparison to budesonide/ formoterol.

Conclusion: Fixed dose combination MDIs containing fluticasone/ formoterol and budesonide/ formoterol are effective in elevating pulmonary functions, controlling & relieving symptoms and revamping the quality of life in patients of bronchial asthma. Fluticasone/ formoterol were better in providing a more rapid and greater improvement in percent predicted PEFR, controlling daytime symptoms for a longer time and reducing the need for rescue therapy. Both the treatments were well tolerated.

Keywords:

Bronchial asthma ; Fluticasone; Formoterol; Budesonide

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