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Randomized controlled trial of clemastine fumarate for treatment of experimental rhinovirus colds.

Abstract
We used a rhinovirus challenge model to test the therapeutic efficacy of clemastine fumarate for reducing sneezing and nasal secretion in a double-blind, randomized clinical trial. Clemastine fumarate (1.34 mg) or placebo was administered at 8 A.M. and 8 P.M. for 4 days, beginning 24 hours, 36 hours, 48 hours, and 60 hours after viral challenge. Infected evaluable subjects who received clemastine (n = 75) had reduced sneeze-severity scores compared with those who received placebo (n = 75) on illness days 2 (0.3 vs. 0.5; P = .003), 3 (0.4 vs. 0.8; P = .0003), 4 (0.3 vs. 0.5; P = .025), and 5 (0.1 vs. 0.3; P = .03); sneeze counts for infected evaluable subjects (vs. counts for those who received placebo) were reduced on illness days 2 (1.5 vs. 3.1; P = .01), 3 (1.7 vs. 5.6; P = .0001), and 5 (0.7 vs. 1.9; P = .03). Infected evaluable subjects who received treatment had reduced rhinorrhea scores (compared with those who received placebo) on illness days 2 (0.7 vs. 1.0; P = .04) and 3 (0.6 vs. 0.9; P = .04) and had reduced nasal secretion weights on day 3 (3.6 g vs. 6.3 g; P = .03). Over 4 days of treatment, mean sneeze scores for infected evaluable subjects (vs. scores for those who received placebo) were reduced by 50%, mean sneeze counts by 57%, mean rhinorrhea scores by 27%, and mean nasal secretion weights by 35%. Other cold symptoms were unaffected by treatment. Treatment with clemastine was associated with an excess incidence of dry mouth (6%), dry nose (19%), and dry throat (17%).
AuthorsJ M Gwaltney Jr, J Park, R A Paul, D A Edelman, R R O'Connor, R B Turner
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 22 Issue 4 Pg. 656-62 (Apr 1996) ISSN: 1058-4838 [Print] United States
PMID8729205 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Histamine H1 Antagonists
  • Placebos
  • Clemastine
Topics
  • Administration, Intranasal
  • Adolescent
  • Adult
  • Clemastine (therapeutic use)
  • Common Cold (drug therapy)
  • Double-Blind Method
  • Female
  • Histamine H1 Antagonists (adverse effects, therapeutic use)
  • Humans
  • Male
  • Middle Aged
  • Mucus (drug effects, metabolism)
  • Nasal Mucosa (metabolism)
  • Nasal Obstruction (drug therapy)
  • Placebos
  • Rhinovirus
  • Sneezing (drug effects)
  • Xerostomia (chemically induced)

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