A study of intranasally administered interferon A (rIFN-α2A) for the seasonal prophylaxis of natural viral infections of the upper respiratory tract in healthy volunteers

SUMMARYThe efficacy of interferon A (rIFN-α2A), an Escherichia coli-derived interferon, in the prophylaxis of acute upper respiratory tract infection, was evaluated in a community-based double-blind placebo-controlled study in the Australian winter of 1985. The trial population of 412 healthy volunteers (190 males and 222 females, aged 18–65 years) self-administered 1·5, 3·0 and 6·0 megaunits (MU) of interferon A per day or a placebo, intranasally for 28 days.The period of study coincided with an outbreak of H3N2 influenza A (detected in 35 of the 107 acute specimens) as well as substantial numbers of respiratory syncytial virus and adenovirus infections. Rhinoviruses were isolated from only three specimens. In many cases, subjects had laboratory and clinical evidence of having had more than one respiratory tract infection during the period of the study. Viruses were detected in 54 or 107 acute specimens (49%).No statistically significant differences were noted between the various treatment groups in the incidence of laboratory-proven viral infection (virus isolation and/or antibody response). Analysis of reported symptoms indicated that blood-tinged mucus and nasal stuffiness occurred more frequently with higher doses of interferon. There appeared to be no clinical benefit from the use of interferon A in the amelioration of symptoms.

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Randomised, Double-Blind, Placebo-Controlled Study of a Single Dose of an Amylmetacresol/2,4-dichlorobenzyl Alcohol Plus Lidocaine Lozenge or a Hexylresorcinol Lozenge for the Treatment of Acute Sore Throat Due to Upper Respiratory Tract Infection

Journal of Pharmacy & Pharmaceutical Sciences ◽

10.18433/j31309 ◽

2012 ◽

Vol 15 (2) ◽

pp. 281 ◽

Cited By ~ 19

Author(s):

Damien McNally ◽

Adrian Shephard ◽

Emma Field

Keyword(s):

Single Dose ◽

Tract Infection ◽

Respiratory Tract ◽

Respiratory Tract Infection ◽

Sore Throat ◽

Controlled Study ◽

Upper Respiratory Tract ◽

Post Dose ◽

Double Blind ◽

Upper Respiratory

Purpose: Sore throat is a frequent reason for seeking medical care but few prescription options are available. Lozenges are effective in delivering active ingredients to the throat. This study was conducted to determine the analgesic efficacy of two lozenges  one containing amylmetacresol (AMC)/2,4-dichlorobenzyl alcohol (DCBA) and lidocaine and one containing hexylresorcinol  versus placebo in patients with acute sore throat due to upper respiratory tract infection (URTI). Methods: This was a multicentre, randomised, double-blind, parallel group, placebo-controlled study. In total, 190 patients were randomised 1:1:1 to a single dose of AMC/DCBA + lidocaine, hexylresorcinol or placebo lozenge. Subjective ratings of throat soreness, difficulty swallowing, swollen throat, numbing, and sore throat relief were obtained up to 2 hours post dose. Patient and investigator global ratings and a consumer questionnaire were also collected. The primary endpoint was the change from baseline in severity of throat soreness for both lozenges versus placebo at 2 hours post dose. Results: The hexylresorcinol lozenge demonstrated superiority over placebo for primary and secondary efficacy variables including those related to throat soreness, sore throat relief and difficulty swallowing; the AMC/DCBA + lidocaine lozenge was also superior to placebo for secondary endpoints at various time points but did not reach significance for the primary efficacy variable. Both lozenges had a rapid onset of action from 1–10 minutes post dose for the AMC/DCBA + lidocaine lozenge and 1–5 minutes post dose for the hexylresorcinol lozenge. Numbness was reported from 1 minute post dose with the AMC/DCBA + lidocaine lozenge and was greatest at 15 minutes. Numbness was reported from 5 minutes post dose with the hexylresorcinol lozenge and was greatest at 10 minutes. Both lozenges were well tolerated. Conclusions: Both AMC/DCBA + lidocaine and hexylresorcinol lozenges provided rapid and effective sore throat relief in patients with URTI. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

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