- A comparison study of therapeutic equivalence of the test and standard fixed-dose combination of 3 mg benzydamine hydrochloride and 1 mg cetylpyridinium chloride in the treatment of sore throat associated with upper respiratory tract infections
A comparison study of therapeutic equivalence of the test and standard fixed-dose combination of 3 mg benzydamine hydrochloride and 1 mg cetylpyridinium chloride in the treatment of sore throat associated with upper respiratory tract infections
Cetylpyridinium chloride is a broad-spectrum antiseptic. Its antibacterial effect has been recognized for many years. Benzydamine is a non-steroidal antiinflammatory drug, an indazole that has analgesic, anti-inflammatory, local anesthetic and antipyretic properties and has been widely used across Europe for nearly 40 years. The objective of our study was to confirm the efficacy and safety of this combination in the treatment of sore throat associated with upper respiratory tract infections. The formulation of 3 mg benzydamine hydrochloride and 1 mg cetylpyridinium chloride (Septabene lozenges, Krka, d.d.) was significantly superior to the placebo and the reference drug in all efficacy criteria. There was an immediate onset of action of the tested investigational medicinal product that was shown by the reduction in throat pain intensity over the initial 15-minute interval period after drug administration. Throat pain was statistically significantly reduced for at least 3 hours in comparison with placebo. Similar improvement was also observed in pain relief over 3 hours. After 4 days of treatment start, pain intensity was reduced for more than 85% from baseline. The treatment was successful in 89% of patients, who received the tested drug. Adverse reactions (dry mouth and heartburn) were reported in 2.54% of subjects treated with the investigational medicinal product. The reactions were evaluated as mild and reduced within 24 hours. Both active treatments had a similar safety profile, which was clinically not significantly different from the placebo. This study demonstrated that tested investigational medicinal product is effective and well tolerated, as well as serves as an appropriate treatment option for patients with sore throat associated with upper respiratory tract infections.
Key words: sore throat; cetylpyridinium chloride; benzydamine hydrochloride; analgesic; anti%inflammatory; antiseptic
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