Comparative effects of desloratadine versus montelukast on asthma symptoms and use of beta 2-agonists in patients with seasonal allergic rhinitis and asthma

Int Arch Allergy Immunol. 2003 Apr;130(4):307-13. doi: 10.1159/000070218.


Background: Asthma and seasonal allergic rhinitis (SAR) are recognized as manifestations of a single airway disease. Desloratadine has demonstrated efficacy in treating SAR symptoms, including nasal obstruction.

Methods: Safety and efficacy of desloratadine and montelukast each were assessed in a double-blind, placebo-controlled trial of patients with SAR and symptoms of asthma, who were assigned randomly to once-daily treatment with desloratadine 5 mg, montelukast 10 mg, or placebo for 4 weeks. Change from baseline of AM/PM reflective total asthma symptom severity scores (TASS), FEV(1), individual asthma symptom scores, and beta(2)-agonist usage were assessed.

Results: Desloratadine and montelukast each were associated with statistically significant reductions from baseline in the mean TASS averaged over the 4-week period (p < or =0.022 vs. placebo). Individual asthma symptom scores also improved significantly for both therapies (p < or = 0.05). Patients treated with desloratadine or montelukast demonstrated improvement from baseline in FEV(1) versus placebo; significant improvement was seen in a subset of patients with baseline FEV(1) <80% of predicted normal (both p < 0.05). Both active therapies significantly reduced beta(2)-agonist use (both p < 0.01). Improvements for both therapies were comparable for all efficacy parameters; they were tolerated well with adverse event profiles similar to placebo.

Conclusions: Asthma symptoms and beta(2)-agonist were improved significantly in patients with concomitant SAR and asthma treated with desloratadine 5 mg as well as montelukast 10 mg once daily. Both therapies significantly improved FEV(1) in a subset of patients with FEV(1) <80% of predicted normal at entry. Improvements in asthma symptoms were comparable for both active treatment groups.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acetates / therapeutic use*
  • Adolescent
  • Adrenergic beta-Agonists / therapeutic use*
  • Adult
  • Aged
  • Albuterol / therapeutic use*
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / complications
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Double-Blind Method
  • Female
  • Histamine H1 Antagonists, Non-Sedating / therapeutic use*
  • Humans
  • Loratadine / analogs & derivatives
  • Loratadine / therapeutic use*
  • Male
  • Middle Aged
  • Pulmonary Ventilation / drug effects
  • Quinolines / therapeutic use*
  • Rhinitis, Allergic, Seasonal / complications
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Rhinitis, Allergic, Seasonal / physiopathology
  • Treatment Outcome


  • Acetates
  • Adrenergic beta-Agonists
  • Anti-Asthmatic Agents
  • Histamine H1 Antagonists, Non-Sedating
  • Quinolines
  • Loratadine
  • desloratadine
  • montelukast
  • Albuterol