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We evaluated the efficacy and tolerability of oral pleconaril, an anti-picornavirus agent, in treating acute viral respiratory illness (VRI) in two double-blind, placebo-controlled trials. Otherwise healthy subjects, 14 years of age or older, who presented within 36 h of VRI symptom onset, were randomized to pleconaril 400 mg or matching placebo in liquid (first trial) or tablet (second trial) formulations twice-daily (first trial only) or three-times daily for 7 days. The infected subjects from the corresponding active and placebo groups (three-times daily dosing regimens) were combined for analysis. Among the subset of subjects with proven picornaviral infection in both studies (42% of total enrolled), pleconaril 400 mg three-times daily ( n=323) reduced the time to alleviation of illness (no rhinorrhoea and other symptoms mild or absent for ≥48 h) compared with placebo ( n=264) (median: 10.0 days for placebo and 8.5 days for pleconaril; P=0.029). In addition, pleconaril reduced the time to a ≥50% reduction from baseline in total symptom severity score (median: 4.5 days for placebo and 3.5 days for pleconaril; P=0.038). Significant reductions in the number of tissues used for nose-blowing (20% reduction) and in nights of disturbed sleep (16% reduction) were also observed. Pleconaril was generally well tolerated; the liquid formulation caused gastrointestinal disturbance in all groups (diarrhoea 10–14%, nausea 5–9%, abdominal discomfort 6–8%), and tablets were associated with a greater incidence of nausea (3% for placebo versus 7% for pleconaril, P=0.003). Pleconaril 400 mg administered three-times daily reduced the duration and severity of picornaviral VRI in adolescents and adults.

Oral Pleconaril Treatment of Picornavirus-Associated Viral Respiratory Illness in Adults: Efficacy and Tolerability in Phase II Clinical Trials