What is the role of montelukast (leukotriene receptor antagonist) in a patient with repetitive Upper Respiratory Tract Infections (URTI) and suspected underlying asthma or allergic rhinitis?

Montelukast Has No Role in Preventing Repetitive URTIs

Montelukast should not be used for the prevention or treatment of repetitive upper respiratory tract infections (URTIs), as it has no proven efficacy for viral respiratory infections. 1 The only appropriate role for montelukast in a patient with repetitive URTIs is if they have documented underlying asthma or allergic rhinitis requiring treatment for those specific conditions. 2, 3

Evidence Against Montelukast for URTI Prevention

• A high-quality randomized controlled trial in 300 preschool children (ages 1-5 years) without reactive airway disease demonstrated that 12 weeks of prophylactic montelukast 4 mg daily, compared to placebo, did not reduce the incidence of URTIs (30.4% vs 30.7% of weeks with URI reported, no significant difference). 1

• There was no significant difference in any secondary variables between montelukast and placebo groups for URI prevention. 1

• Montelukast's mechanism of action targets cysteinyl leukotriene receptors involved in allergic inflammation and asthma pathophysiology, not viral infection pathways. 4

When Montelukast IS Appropriate in Patients with Repetitive URTIs

Consider montelukast only if the patient has documented comorbid conditions:

For Allergic Rhinitis

• Montelukast produces statistically significant improvement in nasal symptoms and quality of life scores compared to placebo in patients with allergic rhinitis. 2, 3

• However, intranasal corticosteroids are strongly preferred over montelukast for initial treatment of seasonal allergic rhinitis (strong recommendation). 2

• Montelukast is less effective than intranasal corticosteroids for allergic rhinitis. 2, 3

• Oral antihistamines are also preferred over montelukast for seasonal allergic rhinitis. 2

• Montelukast may be considered as an alternative for patients who cannot tolerate or refuse intranasal corticosteroids, or for parents who are "steroid-phobic." 2, 3

For Coexisting Asthma and Allergic Rhinitis

• This is the most appropriate scenario for montelukast use: when a patient has both conditions, as montelukast can treat both the upper and lower airway simultaneously. 2, 3, 5

• In patients with mild persistent asthma and coexisting allergic rhinitis, montelukast has been recommended for monotherapy. 2

• Montelukast provides significant relief from seasonal allergic rhinitis symptoms while conferring benefit for asthma in patients with both conditions. 5

• Combination therapy with montelukast and a second-generation antihistamine may provide better protection against seasonal decrease in lung function in patients with both conditions. 2

For Asthma Alone

• Montelukast is appropriate for mild persistent asthma as an alternative to inhaled corticosteroids in patients unable or unwilling to use them. 3

• Montelukast is safe and effective for asthma management in children as young as 6 months. 2, 4

Clinical Pitfalls to Avoid

• Do not prescribe montelukast for "recurrent colds" or viral URTIs - there is no evidence of benefit and this represents inappropriate use. 1

• Do not assume that repetitive URTIs indicate underlying asthma without proper diagnostic evaluation (spirometry, bronchodilator response, or peak flow variability).

• Be aware that montelukast has FDA warnings about serious behavior and mood-related changes, including suicidal thoughts or actions, which must be weighed against benefits. 6

• Onset of action for montelukast occurs by the second day of treatment, unlike antihistamines which work more quickly. 2, 3

• Montelukast does not significantly suppress skin tests, which can be advantageous when allergy testing is needed. 2, 3

Practical Algorithm

Step 1: Determine if repetitive URTIs are truly viral infections or if symptoms suggest allergic rhinitis (clear rhinorrhea, sneezing, nasal itching, eye symptoms, seasonal pattern, allergen triggers).

Step 2: If allergic rhinitis is suspected, confirm diagnosis and initiate intranasal corticosteroids as first-line therapy. 2

Step 3: Evaluate for asthma (wheezing, cough, chest tightness, exercise limitation, nocturnal symptoms) with objective testing if indicated.

Step 4: Consider montelukast only if:

• Patient has documented allergic rhinitis AND asthma (preferred scenario) 2, 3, 5, OR
• Patient has allergic rhinitis but refuses/cannot tolerate intranasal corticosteroids 2, 3, OR
• Patient has mild persistent asthma requiring controller therapy 3

Step 5: Do not prescribe montelukast for URTI prevention in the absence of these conditions. 1