Efficacy and tolerability of astemizole-D and Loratadine-D during prolonged, controlled allergen challenge in the Vienna Challenge Chamber.
This randomized, double-blind, single-dummy, cross-over trial was initiated to compare the efficacy and tolerability of once-daily astemizole-D (CAS 141623-30-5; 10 mg astemizole/240 mg pseudoephedrine) with twice-daily loratadine D (CAS 132316-36-0; 5 mg loratadine/120 mg pseudoephedrine) during prolonged, controlled allergen challenge in the Vienna Challenge Chamber. Twelve atopic patients participated in this study with a treatment duration of 3 days. Pollen challenges were made on days 1 and 3: the first to assess onset of drug action; the second to determine duration of drug effect. Drug efficacy was assessed using a number of standard objective and subjective measures. Onset of action was found to be generally comparable in both treatment groups for all parameters tested with a mean overall onset of action of 65 min during treatment with astemizole-D compared with 70 min on loratadine-D. As expected, astemizole-D tended to have a longer duration of action, with symptom severity lower with this agent than with loratadine-D during the second challenge session despite the differences in dosing schedule. However, inter-group differences did not attain statistical significance. Patient evaluations of therapeutic efficacy confirm these findings. Both drugs were well-tolerated, although a non-significant trend towards greater sleep impairment was seen during treatment with loratadine-D. In conclusion, astemizole-D was shown to be at least as effective and well tolerated as loratadine-D for the treatment of allergen-induced rhinoconjunctivitis during prolonged, controlled allergen challenge.
Horak
F
F
Ear, Nose, Throat Clinic, University of Vienna, Austria.
Jäger
S
S
Toth
J
J
Berger
U
U
D000328:Adult; D000403:Airway Resistance / Q000187:drug effects; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000494:pharmacology*; D016589:Astemizole / Q000009:adverse effects / Q000494:pharmacology*; D001985:Bronchial Provocation Tests; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000503:physiopathology; D017336:Loratadine / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D012129:Respiratory Function Tests; D012890:Sleep / Q000187:drug effects
D018926:Anti-Allergic Agents; D017336:Loratadine; D016589:Astemizole