The study aims to evaluate the effectiveness and safety of Atusin® CAP in reducing the severity of acute bronchitis.
A prospective, multicenter, double-blind, placebo-controlled, randomized, parallel study will be conducted to evaluate the effect of Atusin® CAP on the rapid relief of irritating cough in adults with acute bronchitis treated in actual clinical practices in primary healthcare, where patients seek help as a result of serious complaints. The combination of the three extracts: a mix of essential oils, bromelain and green Brazilian propolis may represent a breakthrough in symptomatic treatment by blocking the triggering mechanisms of cough due to acute bronchitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
310
This food supplement contains a distillate of 4 types of purified oils - eucalyptus, sweet orange, lemon and myrtle, rich in 1,8-cineol, limonene, alpha-pinene in the ratio: 66:32:1:1, bromelain and green Brazilian propolis in a gastro-resistant capsule. The product contains excipients: microcrystalline cellulose, silica dioxide, copovidone, magnesium stearate.
The placebo product will be identical in shape, appearance and color to the active product and will have the same composition but without the active ingredients.
University Hospital "St George"
Plovdiv, Bulgaria
Bronchitis severity assessment
The bronchitis severity assessment will be performed using the Bronchitis Severity Scale by the Investigator. The intensity of symptoms - frequency of coughing attacks, sputum discharge, rales on auscultation, chest pain on coughing and dyspnea will be assessed using a 5-point Likert scale: 0=Absent (1-2 times/day), 1=mild (3-5 times/day), 2=moderate (6-10 times/day), 3=severe (11-20 times/day), 4=very severe (\>20 times/day). Clinical cure is defined as ⩾75% reduction in baseline Bronchitis Severity Scale after 10 days.
Time frame: Up to 14+2 days after starting treatment
Reduction in cough severity
The severity of the cough by Visual Analogue Scale (VAS) is a single element measure of the subject's current perception of the severity of the cough. It is rated on a scale of 10 cm (100 mm), where "0" stands for "Absent" and "10" represents "The most severe possible cough". The decrease in cough severity per VAS by ⩾ 20 mm is assumed to be significant in this study.
Time frame: Up to 14+2 days after starting treatment
Reduction of the duration (in days) of moderate to severe cough
Number of continuous days with moderate to severe cough. The severity of cough is assessed by the subject every evening at bedtime on Day 1 through Day 10, using the Visual Analogue Scale (VAS). The duration of moderate to severe cough will be calculated taking into account the number of consecutive days (2, 3,..10) in which the subject noted severity of cough of ≥ 5.
Time frame: up to 14+2 days after start of treatment
Frequency of daytime cough attacks
An attack is defined as a single cough of 3 or more consecutive coughs. Evaluated by: * Investigator at subject enrollment, during screening at Visit 1 (V1) (Day 1), and the data will serve as a baseline, and on V2, V3 and V4 using the Bronchitis Severity Scale. * Subject every evening at bedtime on Day 1 through Day 10, using an Acute Bronchitis Severity Score.
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Time frame: Up to 14+2 days after start of treatment
Reduction in the frequency of nocturnal cough
The baseline frequency of cough attacks is evaluated by the Investigator at subject enrollment during screening Visit 1 (V1; CRF record) Day 1, using the Bronchitis Severity Scale and by the subject every evening at bedtime on Day 1 through Day 10, using the Acute Bronchitis Severity Score. The frequency of nighttime cough will be assessed daily from Day 1 (enrollment) to Day 10 and changes in its frequency will be analyzed after 1-10 days from baseline (change in day/night cough frequency after k days of treatment = frequency of day/night cough after k days of treatment - frequency of cough at enrollment (Day 1), where k = 1, 2,…,10).
Time frame: Up to 10 days after the start of treatment
Quality of life (QoL)
Limitation of daily activity is assessed by the Investigator at trial entry and by subject every evening at bedtime on Day 1 through Day 10 using the Acute Bronchitis Severity Score (ABSS).
Time frame: Up to 10 days after start of treatment
Adverse events
Incidence of mild (e.g. self-resolving), moderate (e.g. those requiring medical evaluation) and severe (e.g. those requiring prolonged hospitalization) serious and non-serious adverse events.. Recorded daily by the subjects in ePD and by Investigators in eCRF
Time frame: Up to 14+2 days after starting treatment
Response to treatment
At each visit during/after treatment (V2, V3 and V4), response to treatment is assessed by the Investigator using a verbal rating scale (VRS): 0 = symptoms resolved \[resolved\], 1 = symptoms improved compared to baseline, 2 = symptoms unchanged compared to baseline, 3 = symptoms worsened compared to baseline. Subjects with points 0 or 1 are defined as "responders"; subjects with points 2 or 3 were defined as "non-responders".
Time frame: Up to 14+2 days after starting treatment