Abstract | BACKGROUND: OBJECTIVES: To assess the efficacy and safety of DL in subjects with IAR based on the ARIA classification. METHODS: Patients over 12 years of age with IAR were assessed over 15 days of treatment with DL 5 mg once daily (n = 276) or placebo (n = 271). The primary endpoint was the AM/PM reflective total 5 symptom score (T5SS). Secondary endpoints included AM/PM instantaneous T5SS and individual symptoms, therapeutic response, symptom severity by visual analogue scale, and quality-of-life. RESULTS: The mean reduction of AM/PM reflective T5SS was significantly greater with DL than with placebo over 15 days (-3.01 vs-2.13, P < 0.001) and on each individual day (P < 0.05). Mean AM instantaneous T5SS was reduced significantly with DL compared to placebo as early as day 2 (-1.84 vs-0.89; P < 0.001). The therapeutic response and improvement in quality-of-life were significantly greater with DL than with placebo (P < 0.001 for each). The frequency of treatment-related adverse events was low and similar between DL (7.2%) and placebo (7.0%). CONCLUSIONS: This is the first large trial to show that treatment can be effective in IAR. Desloratadine was effective and safe.
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Authors | J Bousquet, C Bachert, G W Canonica, J Mullol, P Van Cauwenberge, C Bindslev Jensen, W J Fokkens, J Ring, P Keith, R Lorber, T Zuberbier, ACCEPT-1 study group |
Journal | Allergy
(Allergy)
Vol. 64
Issue 10
Pg. 1516-1523
(Oct 2009)
ISSN: 1398-9995 [Electronic] Denmark |
PMID | 19624554
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Histamine H1 Antagonists, Non-Sedating
- Loratadine
- desloratadine
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Topics |
- Adult
- Double-Blind Method
- Female
- Histamine H1 Antagonists, Non-Sedating
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Loratadine
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Male
- Middle Aged
- Quality of Life
- Rhinitis, Allergic, Perennial
(drug therapy, physiopathology)
- Rhinitis, Allergic, Seasonal
(drug therapy, physiopathology)
- Severity of Illness Index
- Time Factors
- Treatment Outcome
- Young Adult
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