The common cold: Effects of intranasal fluticasone propionate treatment,☆☆,,★★

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Abstract

Objective: A double-blind, randomized, placebo-controlled trial was conducted to study the effect of the intranasal corticosteroid, fluticasone propionate (FP), in the naturally occurring common cold. Methods: One hundred ninety-nine young adults received high-dose FP (200 μg four times daily) or placebo beginning 24 to 48 hours after onset of the common cold for 6 days. All symptoms were recorded on diary cards on days 1 to 20, and clinical examinations were carried out on days 1, 7, and 21. Nasopharyngeal aspirates were collected on days 1 and 7 for detection of rhinoviruses (found in 105 subjects) and Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis (found in 52 subjects) in the nasopharynx. Results: In general, FP treatment had no clinically recognizable effects on the symptoms of the common cold, although it significantly reduced nasal congestion and cough on some study days. After treatment, rhinoviruses were cultured more often in the FP treatment group (37% vs 14%, p < 0.001), but this had no effect on the symptoms of common cold. FP treatment produced no changes in the colonization of pathogenic bacteria in the nasopharynx. Some symptoms of common cold were significantly more severe during days 1 to 10 (p < 0.05) in subjects found to have positive cultures for S. pneumoniae, H. influenzae, or M. catarrhalis in the nasopharynx on day 1 (n = 33). Conclusion: FP treatment does not have any marked effects on the symptoms of the common cold. FP treatment induced prolonged shedding of viable rhinoviruses. Some symptoms of the common cold were significantly more severe in subjects with pathogenic bacteria in the nasopharynx. (J Allergy Clin Immunol 1998;101:726–31.)

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Volunteers

Two hundred young adults were enrolled in the study. The study period was from November 1994 to November 1995, excluding the summer months (June, July, and August 1995). Subjects were recruited through advertisements in local newspapers, through posters in student canteens, and by contact persons. All subjects were of the white race. The mean age (± SD) of male subjects (n = 59) was 24.0 years (± 2.7 years), and that of female subjects (n = 141) was 24.1 years (± 3.6 years). An entry criterion

Subjects

There were no significant differences in the demographic characteristics between the two treatment groups on day 1. One hundred ninety-nine subjects (99.5%) completed the study according to the protocol. One patient (in the placebo group) was excluded on day 7 because of improper use of study medication. On day 21, 63% of the subjects were asymptomatic. No patients had symptoms requiring an additional follow-up visit after day 21.

Effects of the FP treatment

No differences were seen in the frequency of symptoms between the

DISCUSSION

Several recent studies have shown some relief of symptoms in the common cold with ipratropium bromide, first-generation antihistamines, and combined interferon-antimediator therapy. 12 Two previous studies investigated the efficacy of corticosteroids in the treatment of the common cold. The placebo-controlled study of Farr et al.13 examined the efficacy of a combination of intranasal beclomethasone and oral prednisone in experimental rhinovirus infection. Beclomethasone was started 4 days

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From the Departments of aPediatrics, bPulmonary Diseases, and Clinical Allergology, University of Turku, Turku; cthe Department of Pediatrics, University of Oulu, Oulu; and dGlaxoWellcome Ltd.

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Supported by the Academy of Finland, GlaxoWellcome Ltd., the Sigrid Juselius Foundation, and the Turku University Foundation.

Reprint requests: Tuomo Puhakka, MD, Research Unit, Department of Pediatrics, Vähä Hämeenkatu 1 A 3, 20500 Turku, Finland.

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