Montelukast versus fluticasone: effects on lung function, airway responsiveness and inflammation in moderate asthma

Abstract

Whether leukotriene receptor antagonists exhibit adequate antiinflammatory effects in the treatment of asthma is still a controversial issue. The aim of the present study was to perform a direct comparison of the effects of a 4-week treatment with either montelukast (10 mg, once a day) or low-dose inhaled fluticasone (100 mg b.i.d.) on functional and inflammatory parameters in steroid-naïve patients with moderate asthma.Forty patients (forced expiratory volume in one second (FEV1), 60-80% predicted) were studied in a double-blind, randomised, crossover design. Treatment periods were separated by 3-8 weeks of washout. At the beginning and end of each period, FEV1, airway responsiveness to inhaled methacholine (provocative concentration causing a 20% fall in FEV1 (PC20)), the level of exhaled nitric oxide (NO) and sputum differential cell counts were determined. Only short-acting b 2 -agonists were allowed for relief of symptoms.FEV1 increased by 0.50¡0.07 L (mean¡SEM) after fluticasone and by 0.37¡0.07 L after montelukast (pv0.001, each), and PC20 by 1.33¡0.13 (pv0.001) and 0.15¡0.17 (NS) doubling doses, respectively. Correspondingly, percentages of sputum eosinophils were reduced by factor 2.7 (pv0.01) and 1.4 (nonsignificant (NS)), and the levels of exhaled NO (at 50 mL?s -1 ) by factor 2.1 (pv0.01) and 1.1 (NS). These data indicate a comparable bronchodilator action of montelukast and fluticasone in patients with moderate asthma, but additional attenuation of airway inflammation by fluticasone as detectable through noninvasive methods.

Dose reduction of inhaled corticosteroids under concomitant medication with montelukast in patients with asthma

“…Not all studies, however, reported on such effects, including an anti-inflammatory action of montelukast [12]. In contrast to the expected 75% protection of the deterioration in PEF under placebo, the actual protection through montelukast was y20% and was nonsignificant.…”

“…However, whether clinically introduced antileucotrienes exert significant anti-inflammatory effects is still under discussion. Some studies have shown a reduction in, for example, sputum eosinophils or the level of exhaled NO, whilst others have not [10][11][12]. Irrespective of this, antileucotrienes undisputedly have a bronchodilator and bronchoprotective potential [12,13] and have thus became part of current treatment recommendations in asthma [1].…”

The effect of montelukast on lung function and exhaled nitric oxide in infants with early childhood asthma

“…Montelukast has been found to cause a significant decrease in the levels of sputum eosinophil cationic protein [23], soluble interleukin-2 receptor, interleukin-4 and soluble intercellular adhesion molecule-1 and eosinophil blood counts [18]. While studies in adults [20,25,30] and school-aged children [9,31] treated with montelukast have shown a fall in FeNO, the data from the present study illustrate that this effect of montelukast on FeNO is also present in infants and very young children aged ,2 yrs suffering from early childhood asthma. A significant reduction in FeNO after 4 weeks of treatment with montelukast has been shown in the present study.…”

“…Although some studies have demonstrated a positive effect on markers of airway inflammation [9,18,20,23,24], namely FeNO and levels of sputum eosinophils and eosinophil cationic protein, others have not [25]. Montelukast is orally administered once daily and is therefore easy to apply.…”

Sample sizes for clinical trials using sputum eosinophils as a primary outcome

“…Reporting of sample size calculation Of the 361 search results, 20 studies fulfilled the inclusion criteria [9,[13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32]. 11 of the 20 (55%) did not report how the sample size was calculated.…”