The BSS - A Valid Clinical Instrument to Measure the Severity of Acute Bronchitis

Lehrl, S; Matthys, H; Kamin, Wolfgang; Kardos, Péter

doi:10.15406/jlprr.2014.01.00016

Cited by 11 publications

(5 citation statements)

References 34 publications

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“…Total Bronchitis Severity Scale: Relationship to severity of acute bronchitis[24] (score in this study not> 15) …”

mentioning

confidence: 70%

“…Change in the total score of the Bronchitis Severity Scale (BSS), a standardized and validated questionnaire to assess the severity of acute bronchitis, was evaluated as a secondary endpoint: The BSS comprises the following five symptoms typical for AB: cough, sputum production, cough induced chest pain, rales on auscultation, and dyspnea [24]. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe.…”

Section: Outcome Measuresmentioning

confidence: 99%

“…These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe. The points allocated to each of the symptoms are added to make the total score, which can therefore vary between 0 and 20 points (see Table 1) [1,24]. In addition to the total score, the individual scores of each symptom were assessed in the study.…”

Section: Outcome Measuresmentioning

confidence: 99%

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Efficacy and safety of Cineole (Soledum®) in the treatment of patients with acute bronchitis: results of an open-label randomized clinical phase III study

Kardos

Khaletskaya

Kropova³

2021

Clin Phytosci

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Background Cineole has documented anti-inflammatory, expectorant, and mucolytic properties and has shown to be a valuable treatment option in different airway diseases. Our study examined whether a therapy with Cineole as add on to an antiviral therapy can relieve symptoms of acute bronchitis, and accelerate recovery in everyday practice. Methods In an open-label, randomized, parallel-group phase III clinical trial, 132 patients diagnosed with “acute bronchitis” or “acute tracheobronchitis” were included and treated with 3 × 200 mg of Cineole on top of antiviral treatment, or antiviral treatment alone (Ingavirin® 90 mg), per day for 4–9 days. The primary outcome measure was the change in cough frequency assessed in a Cough Frequency Assessment Scale, secondary outcomes were the total Bronchitis Severity Scale (BSS), as well as individual symptoms of the BSS score. Adverse events were collected for safety analysis. The study sites were located in Russia. Results After 4 days of therapy, there was a significant difference between the groups in favour of the patients treated with Cineole which persisted until the end of the study. At that time, cough during the day, assessed by the Cough Frequency Assessment Scale, was absent in 14 patients in the Cineole group (21.5%), compared to 4 (6.2%) patients in the control arm (p = 0.0203), which was replicated using the BSS individual cough score. In addition, significant improvements in the individual symptoms of the BSS in patients taking Cineole were documented. The study drug showed good tolerability without differences to antiviral treatment and results were in line with previous experiences with this drug. Conclusions Assessment after 4 days of treatment with additional Cineole showed a significant reduction of cough frequency and other symptoms of acute bronchitis compared to antiviral treatment alone. In addition, patients recovered faster from the disease. Additional treatment with Cineole is a valuable treatment option in acute bronchitis. Trial registration Ministry of Health, Russia, No. 592. Registered 19 October 2015.

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“…Total Bronchitis Severity Scale: Relationship to severity of acute bronchitis[24] (score in this study not> 15) …”

mentioning

confidence: 70%

Section: Outcome Measuresmentioning

confidence: 99%

Section: Outcome Measuresmentioning

confidence: 99%

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Efficacy and safety of Cineole (Soledum®) in the treatment of patients with acute bronchitis: results of an open-label randomized clinical phase III study

Kardos

Khaletskaya

Kropova³

2021

Clin Phytosci

Self Cite

View full text Add to dashboard Cite

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“…The patient population in this trial consisted of male and female adults aged 18 to 73 years old, who were diagnosed with acute bronchitis and subsequently recruited from the patient pool of the investigators, based on clinical symptoms. Investigators assessed the symptoms (of which the lead symptom was cough) using the Bronchitis Severity Score (BSS), which is a published, validated tool to measure the severity of acute bronchitis [3, 14]. The patients had to have been symptomatic for 2–3 days before beginning the treatment and scoring ≥10 points in the BSS scale, ≥2 points on the Visual Category Descriptive (VCD) scale and ≥50 mm on a visual analogue scale (VAS) of cough severity.…”

Section: Methodsmentioning

confidence: 99%

“…The BSS is a sum score composed of the symptoms coughing, sputum, rattling noise, thorax pain and dyspnoea, each being rated on a point scale from 0 to 4 (0, absent; 1, mild; 2, moderate; 3, severe; 4, very severe), leading to a maximum value of 20 points. This score has been validated for the evaluation of bronchitis [14].…”

Section: Methodsmentioning

confidence: 99%

Efficacy of two dosing schemes of a liquid containing ivy leaves dry extract EA 575 versus placebo in the treatment of acute bronchitis in adults

Schaefer¹,

Ludwig

Giannetti³

et al. 2019

ERJ Open Res

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IntroductionThe results of a clinical trial published in 2016 showed the efficacy of ivy leaves dry extract EA 575 versus placebo in the treatment of patients suffering from acute cough. A clinical trial with a very similar design was conducted to not only show the reproducibility of former results but also to investigate an alternative dosing scheme.MethodsThis randomised, placebo-controlled, multicentre, double-blind clinical trial was conducted to assess the efficacy and safety of a liquid containing EA 575 in the treatment of acute bronchitis. A total of 209 patients were treated with a liquid containing EA 575 as an active investigational medicinal product (verum) either two (7.5 mL) or three (5 mL) times a day or placebo in the respective dosing scheme for 1 week, with a total observational period of 2 weeks. The primary efficacy outcome was a change in Bronchitis Severity Score (BSS) of the pooled placebo and pooled verum groups between visits 1 and 5. Additional secondary parameters were assessed, including, for example, change in cough severity as assessed by a visual analogue scale (VAS) and the Verbal Category Descriptive (VCD) score.ResultsSuperiority of verum over placebo was during and at the end of treatment, as measured by BSS. No significant differences between the dosing schemes were observed. VCD scores and VAS measurements also showed the superiority of verum over placebo.ConclusionThe existing data on the clinical efficacy of EA 575 were confirmed. Furthermore, a new dosing scheme was shown to be noninferior to the currently used scheme while maintaining the safety and tolerability of the well-established cough liquid containing EA 575.

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The Effects of Ivy (Hedera helix) on Respiratory Problems and Cough in Humans: A Review

Baharara

Moghadam

Sahebkar

et al. 2021

Natural Products and Human Diseases

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The BSS - A Valid Clinical Instrument to Measure the Severity of Acute Bronchitis

Cited by 11 publications

References 34 publications

Efficacy and safety of Cineole (Soledum®) in the treatment of patients with acute bronchitis: results of an open-label randomized clinical phase III study

Efficacy and safety of Cineole (Soledum®) in the treatment of patients with acute bronchitis: results of an open-label randomized clinical phase III study

Efficacy of two dosing schemes of a liquid containing ivy leaves dry extract EA 575 versus placebo in the treatment of acute bronchitis in adults

The Effects of Ivy (Hedera helix) on Respiratory Problems and Cough in Humans: A Review

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