TY - JOUR
T1 - Oral pleconaril treatment of picornavirus-associated viral respiratory illness in adults
T2 - Efficacy and tolerability in phase II clinical trials
AU - Hayden, Frederick G.
AU - Coats, Teresa
AU - Kim, Kenneth
AU - Hassman, Howard A.
AU - Blatter, Mark M.
AU - Zhang, Bing
AU - Liu, Siyu
PY - 2002/3
Y1 - 2002/3
N2 - 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.
AB - 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.
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M3 - Article
C2 - 12008788
AN - SCOPUS:0036523703
SN - 1359-6535
VL - 7
SP - 53
EP - 65
JO - Antiviral Therapy
JF - Antiviral Therapy
IS - 1
ER -