Clinical studies of combination montelukast and loratadine in patients with seasonal allergic rhinitis.

Abstract

BACKGROUND:

Concomitant use of montelukast and loratadine may improve symptoms of seasonal allergic rhinitis (SAR) more than treatment with either drug alone.

OBJECTIVE:

We compared the efficacy of this combination versus placebo, nasal beclomethasone, montelukast, and loratadine in study 1 and versus placebo, montelukast, and loratadine in study 2.

METHODS:

Patients were randomly allocated to double-blind treatment with intranasal beclomethasone 200 mu g/twice daily (study 1 only), placebo, montelukast 10 mg+loratadine 10 mg, montelukast 10 mg, or loratadine 10 mg once daily. The primary endpoint was the Composite Symptom Score (CSS): average of daily diary scores for Daytime Nasal Symptoms and Nighttime Symptoms.

RESULTS:

In study 1, improvements in the change from baseline in CSS were seen for montelukast+loratadine (least-squares means [95% CI] = -0.43 [-0.51, -0.35]), beclomethasone (-0.57 [-0.64, -0.49]), montelukast, and loratadine. All treatments were significantly better than placebo; montelukast+loratadine had a significantly greater effect on CSS than montelukast alone but no difference compared to loratadine was detected. Beclomethasone provided significantly greater improvement versus montelukast+loratadine on the primary and secondary endpoints except for the rhinoconjunctivitis quality-of-life score. In study 2, the combination treatment was similar to montelukast, loratadine, and placebo for the primary and secondary endpoints.

CONCLUSION:

In study 1, montelukast+loratadine had a significantly greater effect on CSS than placebo and montelukast alone; however, in all comparisons, nasal beclomethasone had a greater effect on daily symptoms. In contrast, the combination of montelukast+loratadine in study 2 did not provide greater improvement compared with placebo, montelukast, or loratadine monotherapy, perhaps due to a large placebo effect.

• Authors: Susan Lu, Marie-Pierre Malice, S Balachandra Dass, Theodore F Reiss
• Journal: The Journal of asthma : official journal of the Association for the Care of Asthma (J Asthma) Vol. 46 Issue 9 Pg. 878-83 (Nov 2009) ISSN: 1532-4303 [Electronic] England
• PMID: 19905912 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Acetates
• Cyclopropanes
• Leukotriene Antagonists
• Quinolines
• Sulfides
• Loratadine
• Beclomethasone
• montelukast

Topics

• Acetates (administration & dosage, adverse effects, therapeutic use)
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Beclomethasone (administration & dosage, adverse effects, therapeutic use)
• Cyclopropanes
• Double-Blind Method
• Drug Therapy, Combination (adverse effects, methods)
• Female
• Humans
• Leukotriene Antagonists (therapeutic use)
• Loratadine (administration & dosage, adverse effects, therapeutic use)
• Male
• Middle Aged
• Quinolines (administration & dosage, adverse effects, therapeutic use)
• Rhinitis, Allergic, Seasonal (diagnosis, drug therapy)
• Sulfides
• Treatment Outcome
• Young Adult