Comparative effects of desloratadine versus montelukast on asthma symptoms and use of beta 2-agonists in patients with seasonal allergic rhinitis and asthma.
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.
Baena-Cagnani
Carlos E
CE
Department of Paediatrics, Infantile Hospital, Santa Rosa, Cordoba, Argentina. baena@powernet.net.ar
Berger
William E
WE
DuBuske
Lawrence M
LM
Gurné
Sandra E
SE
Stryszak
Paul
P
Lorber
Richard
R
Danzig
Melvyn
M
D000085:Acetates / Q000627:therapeutic use*; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000627:therapeutic use*; D006801:Humans; D017336:Loratadine / Q000031:analogs & derivatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012123:Pulmonary Ventilation / Q000187:drug effects; D011804:Quinolines / Q000627:therapeutic use*; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D000318:Adrenergic beta-Agonists; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D039563:Histamine H1 Antagonists, Non-Sedating; D011804:Quinolines; D013440:Sulfides; D017336:Loratadine; C121345:desloratadine; C093875:montelukast; D000420:Albuterol