To compare clinical efficacy of formoterol and fluticasone versus salmeterol and fluticasone in patients of bronchial asthma

A. Rattu¹, A. Goel². ¹Pharmacology, Government medical college , amritsar, Amritsar, India, ²Pharmacology, Government medical college , Amritsar, Amritsar, India.

Introduction: Asthma is an episodic disease with acute exacerbations interspersed with symptom free periods.¹ Formoterol and Salmeterol are two long-acting β2-agonists (LABA). Fluticasone is synthetic inhaled corticosteroids (ICS) with anti-inflammatory effects.² A combination of ICS and LABA is an established and widely used treatment for bronchial asthma when ICSs as monotherapy are ineffective. Fixed-dose combinations of ICS and LABA in a single device are the preferred form of delivery to improve compliance by enabling patients to obtain symptomatic relief by LABAs while receiving the anti-inflammatory benefits of ICSs.³

Methods: The study was randomized, prospective, open label, parallel and comparative, lasting eight weeks, involving 80 patients of bronchial asthma between the age group of 18-60 years, attending the Department of Tuberculosis and Chest Diseases Hospital, Amritsar. Patients were subdivided in Group A and Group B. Group A was administered Formeterol and Fluticasone in the doses of 2 actuations of 6/125 μg twice daily for 8 weeks and Salmeterol and Fluticasone in the doses of 2 actuations of 50/125 μg twice daily for 8 weeks to Group B. Patients in group A and B were assessed on day zero, followed up at 4 weeks and 8 weeks for clinical assessment and computerized spirometry for Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV₁), FEV1/FVC and Peak Expiratory Flow Rate (PEFR).

Results: The mean values for ratio of FEV₁ to FVC at 4^th and 8^th week were 0.59∓0.03 and 0.60∓0.03 respectively in Group A in comparison to the baseline value, 0.60∓0.03, taken at initiation of study. The mean values for ratio of FEV1 to FVC at 4^th and 8^th week were 0.58∓0.04 and 0.59∓0.03 respectively in Group B in comparison to the baseline values which was 0.56∓0.02.

Conclusions: Thus the result shows Formeterol + Fluticasone and Salmeterol + Fluticasone has equal efficacy based on spirometry parameters in the subsequent weeks of follow-up with the baseline values in both the groups.

References:

1. World Health Organization. Asthma and facts about asthma (fact sheet No. 307), Aug 2006 [cited 2007 Dec 12]; Available from: http://www.who.int/mediacentre/factsheets/fs307/en/index.html

2. The British Guidelines on Asthma Management. 1997. Thorax 52:(Suppl. 1)

3. Tan RA, Corren J. Clinical utility and development of the fluticasone/formoterol combination formulation (Flutiform®) for the treatment of asthma. Drug Des Devel Ther. 2014 Sep 30;8:1555–61