Abstract | AIM: MATERIALS AND METHODS: This open-label, randomized, phase III study included patients with acute bronchitis who had a productive cough with difficulty in sputum expectoration. 244 patients were randomized in a 1:1 ratio and received 10 mL of the study drug or reference drug 3 times daily for 2 weeks. After 7 and 14 days of treatment, the physician evaluated patient's subjective complaints and the efficacy of therapy. The primary endpoint was the proportion of patients with high and very high efficacy. RESULTS: The primary endpoint was reached by 70 (0.5738) patients in the study drug group and 54 (0.4426) in the reference drug group (p=0.04). The intergroup difference was 0.1311 [95% confidence interval: 0.0057; 0.2566]. The lower limit of the 95% confidence interval was above zero, which confirms the superiority of therapy with the study drug over therapy with Ascoril Expectorant. The proportion of patients with a 1-point total score reduction and with complete resolution of all symptoms according to the Modified Cough Relief and Sputum Expectoration Questionnaire after 7 and 14 days was numerically higher in the study drug group versus the reference drug group. There were no statistically significant differences between the groups in the incidence of adverse events. CONCLUSION:
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Authors | A A Zaitsev, I V Leshchenko, N A Esaulova, I A Viktorova |
Journal | Terapevticheskii arkhiv
(Ter Arkh)
Vol. 95
Issue 3
Pg. 236-242
(Apr 26 2023)
ISSN: 0040-3660 [Print] Russia (Federation) |
PMID | 37167145
(Publication Type: Randomized Controlled Trial, English Abstract, Journal Article)
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Chemical References |
- Guaifenesin
- Ambroxol
- Expectorants
- Albuterol
- Bromhexine
- Levalbuterol
- Drug Combinations
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Topics |
- Humans
- Adult
- Guaifenesin
(adverse effects)
- Cough
(drug therapy, etiology)
- Ambroxol
(adverse effects)
- Expectorants
(adverse effects)
- Albuterol
(adverse effects)
- Treatment Outcome
- Bronchitis
(diagnosis, drug therapy, chemically induced)
- Bromhexine
(adverse effects)
- Levalbuterol
(therapeutic use)
- Drug Combinations
- Acute Disease
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