Abstract
SummaryBackgroundThe trial aimed to evaluate the efficacy and safety of Spicae aetheroleum (Spicae ae.), a phytomedicine obtained by steam distillation of the flowering tops of Lavandula latifolia, as compared to placebo in adult patients with acute bronchitis.MethodsPatients with uncomplicated acute bronchitis (bronchitis severity score [BSS] ≥ 5 score points) were randomly assigned to treatment with Spicae ae. or placebo in a double-blind, parallel-group design. No additional treatment was admitted. The primary objective was the mean difference of a defined total BSS of 25% between the Spicae ae. and the placebo group after 7 days of full medication dose. Secondary endpoints included the BSS at day 10, additional signs and symptoms of bronchitis, quality of life (QoL) and safety.ResultsThe mean decrease in BSS at day 7 and day 10 was significant with 4.79 vs. 3.20 (p < 0.005 for a 25% difference) and 6.47 vs. 4.32 (p < 0.009 for a 25% difference) score points respectively in the Spicae ae. (n = 119) vs. placebo group (n = 110). Accordingly, most additional signs and symptoms of acute bronchitis as well as the patients’ QoL improved significantly with Spicae ae. as compared to placebo. In all, 258 patients were eligible for safety analysis. The treatment with Spicae ae. was well tolerated; no serious adverse events occurred.ConclusionThe defined objectives both for the primary and secondary endpoints have been met. The results of this study provide evidence that Spicae ae. is well tolerated, effective and superior to placebo in the symptomatic treatment of uncomplicated acute bronchitis in adult patients.
Highlights
Acute bronchitis is a prevalent, self-limited inflammation of the large bronchi in otherwise healthy subjects that is clinically characterized by cough without pneumonia
The results of this study provide evidence that Spicae ae. is well tolerated, effective and superior to placebo in the symptomatic treatment of uncomplicated acute bronchitis in adult patients
Patients were eligible to be included in the study if they were ≥18–75 years of age with a Broca Index between 0.75 and 1.30 and evidence of uncomplicated acute bronchitis (≥10 coughing fits during the last day prior to screening visit, Bronchitis Severity Score [BSS] ≥5 points, onset of first symptoms [bronchial mucus production with impaired ability to cough up] within two days before start of treatment, body temperature
Summary
Acute bronchitis is a prevalent, self-limited inflammation of the large bronchi in otherwise healthy subjects that is clinically characterized by cough without pneumonia. Clinical presentation usually includes acute cough (which may or may not be productive) in response to the infection of the bronchial epithelium, wheezing and hoarseness. It may be accompanied by mild fever (≤38 °C) and a general feeling of tiredness. As the associated coughing episodes can persist for up to eight weeks and adversely affect the quality of patients’ lives they constitute one of the most common reasons why patients seek medical advice [2,3,4,5]
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