Other clinical symptoms

Body temperature

Ability to go to work or school

Other clinical symptoms

Time to decrease body temperature

Number of days with frequent cough

Time to treatment

Adverse event

Frequency of coughing fits

Cough documentation

Response to treatment

Bronchitis Severity Score (BSS)

Difficulty to cough-up mucus during the day

Sleep disturbance due to coughing at night

Work incapacitation

Diary data

Visit data

The rates of resolving individual symptoms

Treatment response according to three criteria

Onset of effect

Change of individual symptoms of the total score

FGK questionnaire

IMOS, IMPSS

Change of individual symptoms of the BSS

FGK questionnaire

Duration of bed rest and ability to attend kindergarten, school or work

IMOS, IMPSS

Change of the individual symptoms of the BSS

Change of further general symptoms

Onset of treatment effect

FGK questionnaire

IMOS, IMPSS

Duration of bed rest and ability to attend kindergarten, school or work

Response to treatment

Change in mean BSS

Change in the ability to cough up mucus during the daytime

Change in sleep disturbance induced by coughing

Change in the patient’s general well-being

ibuprofen 600mg(3x/d) (N=136)

amoxicillin -clavulanic acid 500mg/125mg (3x/d)(N=137)

Efficacy of the treatment at the end of the second follow-up visit

Time of resolution of the total symptom scores

Individual symptoms,

Patinet satisfaction

Adverse events

IMOS, IMPSS

EQ-5

Duration of activity limitation and inability to work assessed

Change of general symptoms,

Treatment compliance

Side effects

Current symptoms

BSS<5 points at study end

Decrease of BSS ≥5 points between baseline and study end

Onset of treatment effect

Consumption of paracetamol

Change of individual symptoms of BSS

Patient’s health status using the health-related quality of life questionnaires(SF-12 Health Survey, EQ-5D)

IMOS, IMPSS

Occurrence of adverse events

Sputum viscosity

Subjective assessments of mucus

at least 2 years of age with a confirmed clinical diagnosis of acute bronchitis

a baseline BSS ≥ 5 points

duration of not more than 48 h

previous medications which may influence the course of the study indication or the evaluation of the target criteria, such as these stated under “Concomitant therapy”.

patients with concomitant diseases like allergic asthma or bronchial hyper reactivity, chronic bronchitis, other chronic or inherited lung diseases, or severe cardiac, hepatic, or renal disorders

18–65 years old

diagnosed with wind-heat syndrome (Chinese medicine symptom score≥ 5)

diagnosed with acute upper respiratory infection or acute bronchitis

within 48hours for acute upper respiratory infection; within 5days from onset for acute bronchitis

symptom severity with mild or moderate, body temperature below 38.5°C

consent to participate

take previous west medication within 2weeks for UTRI

disease like tuberculosis, measles, pertussis, acute tonsillitis, fungus, lung cancer, asthma, bronchial hyper reactivity, pulmonary infection

acute bronchitis with asthma

a pregnant or breast feeding

allergic disease

inflammatory gastrointestinal or hepatic disease or inflammation of the gallbladder or bile duct

symptom severity with serious

aged 18 – 70 years

not longer than 7 days

Bronchitis-Sum-Score of 7 or higher

have severe medical conditions with relevant influence on the acute bronchitis

at least 18 years of age

Brocaindex between 0.75 and 1.30

clinical diagnosis of acute bronchitis as characterized by: ≥ 10 coughing fits during the last day

a baseline BSS ≥ 5 points

on set of first symptoms (bronchial mucus production with impaired ability to cough up) within 2 days before the start of the investigational treatment.

history or presence of confounding respiratory disease (e.g. upper respiratory tract infection within the last 4 weeks, chronic bronchitis or COPD or acute exacerbations of bronchiectasis, asthma, suspected pneumonia, cystic fibrosis, lung cancer);

concomitant bacterial infection

elevated body temperature(>39.5°C rectally or >39.0°C axillary or otic)

active cigarette smoking > 1 pack per day

hypersensitivity to the trial medication

inflammatory gastrointestinal or hepatic disease or inflammation of the gallbladder or bile duct, history or presence of clinically relevant cardiovascular, renal, metabolic, hematological, dermatologic, neurological, psychiatric, systemic or infectious disease

pregnancy or breast feeding, women of childbearing potential without highly effective contraception (failure rate<1%)

participation in a clinical research study within the last 6 weeks

evidence or suspicion of non-compliance, inability to provide informed consent.

diagnosed with acute bronchitis for child

diagnosed with wind-heat syndrome

aged 1–13 years old

symptoms starting within 72h, not yet used antibiotics, antitussive, expectorants and any other drugs that could affect test medication

body temperature within 24h from baseline ≤ 38.5°C

UTRI, suppurative tonsillitis, bronchial asthma, bronchiolitis, pneumonia, lung abscess, measles, pertussis, influenza, an acute infectious disease

malnutrition or immunosuppression

granulocytosis(e.g. suspected bacterial infection), severe heart, renal or liver diseases, immunosuppression

known or supposed hypersensitivity to trial medication

evidence or suspicion of non-compliance

aged 6–18 years old

acute bronchitis with symptoms starting within 48h

BSS≥5 points at screening

treatment with antibiotics, bronchodilators or glucocorticoids during the last 4 weeks, or with analgetics, secretolytics, mucolytics or antitussive during the last 7 days prior to study inclusion

indication for treatment with antibiotics

allergic asthma, tendency to bleed, severe heart, renal or liver diseases and/or immunosuppression, known hypersensitivity against P. sidoides, chronic obstructive pulmonary disease and pregnancy.

aged 1–18 years suffering from acute bronchitis

symptoms starting 48 hours prior to inclusion into the study

BSS≥5points at screening

treatment with antibiotics

allergic asthma, COPD, tendency to bleed, severe heart, renal or liver diseases and/or immunosuppression;

known hypersensitivity against Pelargonium sidoides

pregnancy

aged 1–18 years old

symptoms starting 48h prior to inclusion in the study

BSS≥5points at screening

concomitant medication that may impair the study results (e.g. antibiotics, bronchodilators, glucocorticoids, analgesics other than paracetamol, secretolytics, mycolytics, anti-tussiva, or other bronchitis medication)

allergic asthma, chronic obstructive pulmonary disease, tendency to bleed, severe heart, renal or liver diseases and/or immunosuppression

known hypersensitivity to Pelargonium sidoides

pregnancy

at least 18 years of age,

≥10 coughing fits during the day

onset of bronchial mucus production with impaired ability to cough up at a maximum of 2 days prior to recruitment

BSS ≥ 5points at screening

pregnancy, no contraception for women of child bearing age and lactation for females

the principal ones being concomitant fever(> 39 °C)

pneumonia, history of chronic bronchial or pulmonary disease such as chronic bronchitis, chronic obstructive pulmonary disease (including acute episode), bronchiectasis, bronchial asthma, mucoviscidosis, history of clinically relevant chronic cardiovascular, kidney, gastrointestinal or liver disease, known hypersensitivity to one or more of the active or inactive ingredients of the investigational product, malignant growth, or any severe somatopathic, neurological and/or psychiatric disease.

treatment with other drugs, such as immunosuppressives, systemic antibiotics and systemic or inhaled glucocorticosteroids (within 4 weeks prior to enrolment into the study or concomitantly), mucoactive substances other than the study medication(within 2 weeks prior to enrolment or concomitantly), antitussive drugs and other mucoactive measures except for steam inhalation were not allowed

treatment with angiotensin converting enzyme (ACE) inhibitors was no reason for exclusion if started more than 4 weeks prior to Visit(Paracetamol could be taken in case of fever, other non-steroidal anti-inflammatory drugs were not allowed during the study)

aged 18 to 70 without associated respiratory comorbidity or immunosuppression

respiratory tract infection of less than one week’s duration

with cough as the predominant symptom and discolored sputum and at least one other criterion of lower respiratory tract infection such as dyspnea, wheezing, chest discomfort, or chest pain

antibiotic, anti-inflammatory, or corticosteroid use in the previous two weeks

the presence of radiological signs of pneumonia; signs of severe infection such as confusion

respiratory rate >25 breaths per minute or pulse >120 beats per minute

history of gastrointestinal hemorrhage or intolerance to anti-inflammatory treatment

hypersensitivity to β lactams or intolerance to clavulanic acid or lactose

pregnancy, lactation, and absence of contraception in women of fertile age

associated comorbidity (bronchial asthma, chronic obstructive pulmonary disease, moderate-severe heart failure, dementia, stroke, immunosuppression or the use of immunosuppressive drugs)

emergency situation

in residential care; unable to provide informed consent; difficulty in attending the programmed visits; previous participation in the study; and refusal to participate.

acute bronchitis with symptoms starting within 48h

BSS ≥ 5 points at screening

indication of antibiotic treatment or treatment with antibiotics during the 4-weeks prior to enrolment in the trial

allergic bronchial asthma, tendency to bleed, severe heart, renal or liver diseases, immunosuppression, known or supposed hypersensitivity to trial medication

concomitant medication that might affect trial results or interact with the study medication(e.g. antibiotics)

participation in another clinical trial during the preceding 3 months and patients irresponsible of unable to understand the nature of the study

≥18 years old

symptoms starting 48h or less

participation in any other trial at the same time or within 4 weeks prior to study inclusion

indication for antibiotic treatment, suspected pneumonia

treatment with antibiotics, ACE-inhibitors, β-blockers, bronchodilators, or glucocorticoids within 4 weeks prior to study inclusion

treatment with analgesics, secretolytics, mucolytics, or antitussives during the 7 days prior to study inclusion

allergic bronchial asthma, concomitant bacterial disease or diseases of the upper respiratory tract tendency to bleed, severe heart, renal, or liver diseases and/or immunosuppression

if patients had a fever(39°C), they were allowed to take 500mg paracetamol tablets, but no more than three tablets daily

aged >18 years old

presenting with a productive cough of 2 weeks duration

another potential explanation for cough (history of chronic bronchitis, allergic rhinitis, sinusitis, asthma or gastric reflux),

serious medical comorbidity (heart disease or diabetes), penicillin allergy, antibiotic use in the preceding 2 weeks or a concurrent infection (including tuberculosis) requiring antibiotic treatment.

≥18 years old

acute bronchitis with a BSS ≥ 5 points

duration of complaints ≤ 48 hours

indication for antibiotic treatment, treatment with antibiotics during the past four weeks before inclusion in the trial

allergic bronchial asthma, tendency to bleed, severe heart, renal, or liver diseases, immunosuppression, known or supposed hypersensitivity to the investigational medication

concomitant medication that might impair the study results(eg, antibiotics) or supposed interactions of the concomitant medication with the investigational medication

participation in another clinical trial during the past three months

patients who are known or suspected by their mental capability to be noncompliant

≥18 years old

cough induced by URTIs lasting from 3 to 5 days.

pre-existing respiratory problems

having undergone antibiotic treatment within 7 days prior to enrollment in the study

use of antitussive agents or any other medication that might positively or negatively affect the cough symptom.