Abstract
The aim of this study is to compare the efficacy and safety of a once-daily loratadine-pseudoephedrine sustained release tablet with that of a twice-daily loratadine-pseudoephedrine in the treatment of patients with allergic rhinitis. Forty-eight subjects were randomized into either the treatment or control group. The efficacy endpoint was assessed by total symptom scores (TSS). And the results were analyzed by non-inferiority testing and t-tests. Non-inferiority testing of the once daily loratadine 10 mg-pseudoephedrine 240 mg sustained release tablets to the twice-daily loratadine 5 mg-pseudoephedrine 120 mg combination tablets was not supported by statistical significance. However, both the treatment and control groups showed a significant reduction from the baseline in TSS (P < 0.05), and the difference between groups did not reach statistical significance (P > 0.05). In conclusion, once-daily and twice-daily preparations of loratadine-pseudoephedrine were comparable in efficacy and safety in the treatment of allergic rhinitis.
Original language | English |
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Pages (from-to) | 1019-1025 |
Number of pages | 7 |
Journal | European Archives of Oto-Rhino-Laryngology |
Volume | 264 |
Issue number | 9 |
DOIs | |
State | Published - 09 2007 |
Keywords
- Allergic rhinitis
- Intention to treat
- Loratadine-pseudoephedrine
- Non-inferiority testing
- Total symptom score