A double-blind, placebo-controlled clinical trial of the effect of chlorpheniramine on the response of the nasal airway, middle ear and eustachian tube to provocative rhinovirus challenge.
This paper presents the results of a randomized, double-blind, placebo-controlled study of the efficacy of chlorpheniramine in relieving the symptoms and attenuating the pathophysiologic correlates of a rhinovirus "common cold." Forty healthy, adult, nonatopic subjects were randomly assigned to one of two treatment groups: active drug and placebo. On study Day 0, all subjects were challenged intranasally with rhinovirus type 39 (dose = 100 TCID50). Subjects were cloistered from Day 2 to Day 7, at which time they were treated with either chlorpheniramine or placebo. From 3 days before challenge to study Day 19, subjects had nasal patency assessed by rhinomanometry, eustachian tube function assessed by the 9-step test and sonotubometry, middle ear pressure assessed by tympanometry and nasal clearance assessed by the dyed-saccharin technique. Symptom diaries were maintained throughout the period of follow-up. During cloister, symptoms also were scored by interview, nasal secretions were quantified and nasal washings were performed for viral culture. Results showed that 19 (95%) subjects in the active-treatment group and 18 (90%) subjects in the placebo-treatment group shed virus. Symptomatic colds were observed in 63% of the active-treated and 83% of the placebo-treated subjects. Symptoms increased on Day 1 and peaked at Days 4 to 5. Detrimental changes in other measured functions consistent with those previously reported were observed. During the period of treatment, significant differences in the average symptom scores favoring the active-treatment group were observed for sneezing. Also, weight of expelled secretions was greater and mucociliary clearance rate less on some cloister days for the placebo-treated group. No significant differences between treatment groups in the objective measures of nasal congestion or the response of the middle ear and eustachian tube were documented.
Doyle
W J
WJ
Department of Otolaryngology, Children's Hospital of Pittsburgh, PA 15213-3417.
McBride
T P
TP
Skoner
D P
DP
Maddern
B R
BR
Gwaltney
J M
JM
Uhrin
M
M
D000158:Acoustic Impedance Tests; D000328:Adult; D002744:Chlorpheniramine / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003139:Common Cold / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004432:Ear, Middle / Q000187:drug effects; D005064:Eustachian Tube / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008365:Manometry; D009079:Mucociliary Clearance / Q000187:drug effects; D009093:Mucus / Q000187:drug effects; D009666:Nose / Q000187:drug effects; D011897:Random Allocation; D012912:Sneezing / Q000187:drug effects
D002744:Chlorpheniramine