Abstract | OBJECTIVE: METHODS: A total of 130 patients suffering from grass pollen allergic rhinitis were randomly assigned to 14 days treatment with either emedastine difumarate (2 mg b.i.d.) or terfenadine (60 mg b.i.d.) in a double-blind, randomised, crossover design. Primary efficacy parameter was a Total Severity Symptom Score, including among symptoms nasal congestion, sneezing, rhinorrhea, nasal/throat/palate itching, eye itching and lacrimation. Safety was assessed on routine laboratory tests and recording vital signs and adverse events (AEs). RESULTS:
Emedastine 2 mg b.i.d. was significantly more effective than terfenadine 60 mg b.i.d. in reducing Total Symptom Severity Score (p = 0.0258). This statistical significant difference was also obtained in controlling sneezing and rhinorrhea (p = 0.003). Moreover, both the physician and patients indicated emedastine as the preferred therapy (p < 0.01). Forty-seven drug related AEs were reported for emedastine (= 51.07 %) and 53 for terfenadine (64.15 %), most of them involving the CNS. CONCLUSION:
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Authors | Mario E Corrado, Milko M Radicioni, Jennifer Hartwig, Alessandro Assandri, Hendrik G Oldeman, Alberto Mion |
Journal | Arzneimittel-Forschung
(Arzneimittelforschung)
Vol. 54
Issue 10
Pg. 660-5
( 2004)
ISSN: 0004-4172 [Print] Germany |
PMID | 15553105
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Allergic Agents
- Benzimidazoles
- Terfenadine
- emedastine
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Topics |
- Adolescent
- Adult
- Anti-Allergic Agents
(adverse effects, therapeutic use)
- Benzimidazoles
(adverse effects, therapeutic use)
- Cross-Over Studies
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Rhinitis, Allergic, Seasonal
(drug therapy)
- Terfenadine
(adverse effects, therapeutic use)
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