Observation: children with mild to moderate acute asthma had been stabilized in the ER; upon discharge they received montelukast (Singulair] or oral prednisolone; those receiving the latter, the oral corticosteroids after discharge did better.

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Objective To examine whether outpatient post-stabilization therapy with montelukast produces more treatment failures than prednisolone.

Study design In this randomized, double-blind, double-dummy non-inferiority trial, 130 children 2 to 17 years of age with mild to moderate acute asthma stabilized with prednisolone in the emergency department received 5 daily treatments with either prednisolone or montelukast after discharge. The primary outcome was treatment failure within 8 days (ie, an asthma-related unscheduled visit, hospitalization, or additional systemic corticosteroids).

Results The rates of treatment failure were 7.9% in the prednisolone group and 22.4% in the montelukast group (95% CI, 26.5%–2.4%). Treatment was more likely to fail in younger patients (odds ratio, 4.9). In the montelukast group, more patients received additional pharmacotherapy than in patients receiving prednisolone (23.9% versus 9.5%, P = .03). The differences in the daily salbutamol treatments, asymptomatic days, and changes in the Pediatric Respiratory Assessment Measure score were not significant (P = .85, .75, and .26, respectively).  

Conclusion Montelukast does not represent an adequate alternative to corticosteroids after outpatient stabilization in mild to moderate acute asthma. This population should receive oral corticosteroids after discharge.

Schuh S, Willan AR, Stephens D, et al . " Can Montelukast Shorten Prednisolone Therapy in Children with Mild to  Moderate Acute Asthma? A Randomized Controlled Trial."  J Pediatr  2009;155:795-800  

This was "a randomized, double-blind, doubledummy non-inferiority trial in which study nurses gave all eligible children 2 mg/kg (maximum, 60 mg) oral prednisone or 5 mg/dose prednisolone and nebulized albuterol with 250 mcg/dose ipratropium bromide in 2 mL normal saline via Hudson nebulizer at 0, 30, and 60 minutes and as often as hourly thereafter. Children requiring in-hospital therapy after 8 hours were hospitalized and were not eligible for randomization. Patients discharged from the hospital by hour 8 were randomized to receive either continued 1 mg/kg prednisone/ prednisolone or montelukast (4 mg, 5 mg, and 10 mg in children 2-5, 6-14, and 5-17 years of age, respectively) at 24, 48, 72, 96, and 120 hours after randomization. They were also instructed to take 500 mcg of albuterol via metered dose inhaler/valved holding chamber every 4 hours as needed for 5 more days and to start taking 100 mcg fluticasone twice a day via metered dose inhaler on day 7 for 4 weeks. Children who vomited the experimental medications within 30 minutes received another dose; further vomiting necessitated withdrawal from the study."

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See the other side:  While Singulair may not replace the need for inhaled or systemic corticosteroids, it can often help, meaning more asthma-free days....

Malmstrom K, Rodriguez-Gomez G. Guerra J., et al. "Oral Monoleukast, Inhaled Beclomethasone and Placebo for Chronic Asthma: A Randomized Controllked Trial." Anal Int Med. 1999;130:487-495.

Aubier M, Pieters WR, Schlosser NJJ, Steinmetz K-O. "Salmeterol/Fluticazone propionate (50/500 ug. in Combination in a Discus Inhaler (Seretide) is Effective and Safe in the Treatment of Steroid-Dependent Asthma." Respir. Med. 1999;93:876-884.
[Over a 28 week period, patients on Advair, components of Advair or Fluticizone monotherapy were compared, head-to-head.]

Adding-on Montelukast in Inadequately Controlled Asthma Works

Bronchial asthma often remains uncontrolled despite treatment with inhaled corticosteroids (ICS), long-acting beta(2)-agonists (LABA) or both, necessitating additional treatment. Patients ≥18years (n=1681) with mild-to-moderate asthma received oral montelukast 10mg added to ICS or ICS+LABAs, and were followed for 6months in a prospective, open-label observational study.

• The primary endpoint was change in Asthma Control Test (ACT) score. Mean ACT scores improved from 14.6+/-4.6 (baseline) to 19.4+/-4.4 (month 6; p<0.0001). Using ACT score categories, the percentage of patients with uncontrolled (57.5%) or poorly controlled (25.0%) asthma at baseline decreased at month 6 (17.6 and 21.7%, respectively); the percentage of patients with well controlled (13.9%) or completely controlled (1.2%) asthma at baseline increased at month 6 (47.5 and 11.4%, respectively).
• Secondary endpoints included mini-Asthma Quality-of-Life Questionnaire (mini-AQLQ) and FEV(1)/PEF. The mini-AQLQ score (mean+/-SD) improved from 4.0+/-1.1 to 5.3+/-1.1 (p<0.0001); FEV(1) increased from 2.46+/-0.89 to 2.60+/-0.92L (p<0.0001). Treatment with montelukast was generally well tolerated. 

In patients insufficiently controlled with ICS or ICS+LABAs, daily add-on montelukast improved both asthma control and asthma-related quality of life.

Virchow JC, Mehta A, Ljungblad L, Mitfessel H, the MONICA study group.  "Add-on montelukast in inadequately controlled asthma patients: A 6-month open-label study." Respiratory Medicine (Dec 2009) Clinicaltrials.gov registry number NCT00802789.