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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%).

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  • Authors+Show Affiliations

    ,

    Department of Medicine, University of Virginia Health Sciences Center, Charlottesville 22908, USA.

    , , , ,

    Source

    MeSH

    Administration, Intranasal
    Adolescent
    Adult
    Clemastine
    Common Cold
    Double-Blind Method
    Female
    Histamine H1 Antagonists
    Humans
    Male
    Middle Aged
    Mucus
    Nasal Mucosa
    Nasal Obstruction
    Placebos
    Rhinovirus
    Sneezing
    Xerostomia

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    8729205

    Citation

    Gwaltney, J M., et al. "Randomized Controlled Trial of Clemastine Fumarate for Treatment of Experimental Rhinovirus Colds." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 22, no. 4, 1996, pp. 656-62.
    Gwaltney JM, Park J, Paul RA, et al. Randomized controlled trial of clemastine fumarate for treatment of experimental rhinovirus colds. Clin Infect Dis. 1996;22(4):656-62.
    Gwaltney, J. M., Park, J., Paul, R. A., Edelman, D. A., O'Connor, R. R., & Turner, R. B. (1996). Randomized controlled trial of clemastine fumarate for treatment of experimental rhinovirus colds. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 22(4), pp. 656-62.
    Gwaltney JM, et al. Randomized Controlled Trial of Clemastine Fumarate for Treatment of Experimental Rhinovirus Colds. Clin Infect Dis. 1996;22(4):656-62. PubMed PMID: 8729205.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Randomized controlled trial of clemastine fumarate for treatment of experimental rhinovirus colds. AU - Gwaltney,J M,Jr AU - Park,J, AU - Paul,R A, AU - Edelman,D A, AU - O'Connor,R R, AU - Turner,R B, PY - 1996/4/1/pubmed PY - 2001/3/28/medline PY - 1996/4/1/entrez SP - 656 EP - 62 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin. Infect. Dis. VL - 22 IS - 4 N2 - 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%). SN - 1058-4838 UR - https://www.unboundmedicine.com/medline/citation/8729205/Randomized_controlled_trial_of_clemastine_fumarate_for_treatment_of_experimental_rhinovirus_colds_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1093/clinids/22.4.656 DB - PRIME DP - Unbound Medicine ER -