Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis

A. T. Segal, C. J. Falliers, J. A. Grant, W. K. Podleski, T. R. Woehler, W. J. Huster, B. McNutt

Research output: Contribution to journalArticle

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Abstract

A double-blind, randomized, placebo-controlled, parallel trial was conducted to compare the efficacy and safety of terfenadine, 60 mg (immediate-release)/pseudoephedrine hydrochloride, 120 mg (controlled- release) (T/Ps) and clemastine fumarate, 1.34 mg (immediate- release)/phenylpropanolamine, 75 mg (sustained-release) (C/Ph) in a combination tablet b.i.d. in 178 patients (12-59 years of age) with symptoms of seasonal allergic rhinitis. After seven days of treatment, the total symptom scores recorded in the diaries of 175 patients showed that both therapies had a highly significant overall treatment effect when compared with placebo (P ≤ .02). The overall level of improvement, as well as improvement of individual symptoms, was similar with the two therapies. Total symptom scores assigned by physicians to 170 patients showed significant and similar levels of improvement with both therapies when compared with placebo (P < .01). The two therapies were also similar on physicians' evaluations of overall effectiveness. Both therapies relieved most histamine-mediated symptoms as well as nasal congestion, although only T/Ps showed improvement of the latter symptom in both the patients' diaries and physicians' evaluations. Among 178 patients, drowsiness and fatigue occurred more often in the C/Ph group (25% and 11.7% for the two adverse events, respectively) than in the T/Ps group (10.2% and 1.7%, respectively). The incidence of insomnia and dry mouth/nose/throat was higher with T/Ps (23.7% and 11.9%, respectively) than with C/Ph (6.7% and 3.3%, respectively). No serious or unexpected adverse events were reported. These results indicate that T/Ps and C/Ph are both superior to placebo and equally effective in the treatment of symptoms of seasonal allergic rhinitis. In addition, when used as recommended by current labeling, T/Ps offers a safe, effective alternative to C/Ph, particularly where drowsiness and fatigue may be problematic, but at the expense of developing insomnia and dry-mouth symptoms.

Original languageEnglish (US)
Pages (from-to)389-394
Number of pages6
JournalAnnals of Allergy
Volume70
Issue number5
StatePublished - 1993

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Clemastine
Pseudoephedrine
Phenylpropanolamine
Terfenadine
Seasonal Allergic Rhinitis
Safety
Placebos
Sleep Stages
Sleep Initiation and Maintenance Disorders
Therapeutics
Physicians
Nose
Fatigue
Mouth
Pharynx
Histamine
Tablets

ASJC Scopus subject areas

  • Immunology and Allergy

Cite this

Segal, A. T., Falliers, C. J., Grant, J. A., Podleski, W. K., Woehler, T. R., Huster, W. J., & McNutt, B. (1993). Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis. Annals of Allergy, 70(5), 389-394.

Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis. / Segal, A. T.; Falliers, C. J.; Grant, J. A.; Podleski, W. K.; Woehler, T. R.; Huster, W. J.; McNutt, B.

In: Annals of Allergy, Vol. 70, No. 5, 1993, p. 389-394.

Research output: Contribution to journalArticle

Segal, AT, Falliers, CJ, Grant, JA, Podleski, WK, Woehler, TR, Huster, WJ & McNutt, B 1993, 'Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis', Annals of Allergy, vol. 70, no. 5, pp. 389-394.
Segal, A. T. ; Falliers, C. J. ; Grant, J. A. ; Podleski, W. K. ; Woehler, T. R. ; Huster, W. J. ; McNutt, B. / Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis. In: Annals of Allergy. 1993 ; Vol. 70, No. 5. pp. 389-394.
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abstract = "A double-blind, randomized, placebo-controlled, parallel trial was conducted to compare the efficacy and safety of terfenadine, 60 mg (immediate-release)/pseudoephedrine hydrochloride, 120 mg (controlled- release) (T/Ps) and clemastine fumarate, 1.34 mg (immediate- release)/phenylpropanolamine, 75 mg (sustained-release) (C/Ph) in a combination tablet b.i.d. in 178 patients (12-59 years of age) with symptoms of seasonal allergic rhinitis. After seven days of treatment, the total symptom scores recorded in the diaries of 175 patients showed that both therapies had a highly significant overall treatment effect when compared with placebo (P ≤ .02). The overall level of improvement, as well as improvement of individual symptoms, was similar with the two therapies. Total symptom scores assigned by physicians to 170 patients showed significant and similar levels of improvement with both therapies when compared with placebo (P < .01). The two therapies were also similar on physicians' evaluations of overall effectiveness. Both therapies relieved most histamine-mediated symptoms as well as nasal congestion, although only T/Ps showed improvement of the latter symptom in both the patients' diaries and physicians' evaluations. Among 178 patients, drowsiness and fatigue occurred more often in the C/Ph group (25{\%} and 11.7{\%} for the two adverse events, respectively) than in the T/Ps group (10.2{\%} and 1.7{\%}, respectively). The incidence of insomnia and dry mouth/nose/throat was higher with T/Ps (23.7{\%} and 11.9{\%}, respectively) than with C/Ph (6.7{\%} and 3.3{\%}, respectively). No serious or unexpected adverse events were reported. These results indicate that T/Ps and C/Ph are both superior to placebo and equally effective in the treatment of symptoms of seasonal allergic rhinitis. In addition, when used as recommended by current labeling, T/Ps offers a safe, effective alternative to C/Ph, particularly where drowsiness and fatigue may be problematic, but at the expense of developing insomnia and dry-mouth symptoms.",
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