Abstract | BACKGROUND: 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.
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Authors | Carlos E Baena-Cagnani, William E Berger, Lawrence M DuBuske, Sandra E Gurné, Paul Stryszak, Richard Lorber, Melvyn Danzig |
Journal | International archives of allergy and immunology
(Int Arch Allergy Immunol)
Vol. 130
Issue 4
Pg. 307-13
(Apr 2003)
ISSN: 1018-2438 [Print] Switzerland |
PMID | 12740532
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Copyright 2003 S. Karger AG, Basel |
Chemical References |
- Acetates
- Adrenergic beta-Agonists
- Anti-Asthmatic Agents
- Cyclopropanes
- Histamine H1 Antagonists, Non-Sedating
- Quinolines
- Sulfides
- Loratadine
- desloratadine
- montelukast
- Albuterol
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Topics |
- Acetates
(therapeutic use)
- Adolescent
- Adrenergic beta-Agonists
(therapeutic use)
- Adult
- Aged
- Albuterol
(therapeutic use)
- Anti-Asthmatic Agents
(therapeutic use)
- Asthma
(complications, drug therapy, physiopathology)
- Cyclopropanes
- Double-Blind Method
- Female
- Histamine H1 Antagonists, Non-Sedating
(therapeutic use)
- Humans
- Loratadine
(analogs & derivatives, therapeutic use)
- Male
- Middle Aged
- Pulmonary Ventilation
(drug effects)
- Quinolines
(therapeutic use)
- Rhinitis, Allergic, Seasonal
(complications, drug therapy, physiopathology)
- Sulfides
- Treatment Outcome
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