Management of Acute Bronchitis With Pelargonium Sidoides Extract

Study Overview
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Brief Summary
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The aim of our study is to conduct a pragmatic RCT meeting all required standards to evaluate the effectiveness of Pelargonium sidoides extract, EPs® 7630, in the management of acute bronchitis with or without COVID-19 in PCP practices and walk-in clinics in French-speaking Switzerland. The RCT will be preceded by a pilot phase to ensure its feasibility.

Detailed Description
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The goal of this clinical trial is to evaluate the effectiveness of Pelargonium sidoides extract EPs® 7630, also known under the brand name Kaloba®, in the management of acute bronchitis. The main questions it aims to answer are: Is Pelargonium sidoides extract EPs® 7630 effective to reduce the severity and the duration of symptoms related to acute bronchitis ? Does Pelargonium sidoides extract EPs® 7630 allow to reduce the prescription of antibiotics? Participants will be randomize 1:1 either in the control group (usual care) or in the intervention group (Pelargonium sidoides extract EPs® 7630).

Official Title
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Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial

Conditions
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Acute Bronchitis

Intervention / Treatment
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* Other: Pelargonium sidoides extract EPs® 7630
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (aged 18 and over) consulting for the first time, for the same episode, either for an acute cough (≤8 days) as the main symptom, suggestive of acute bronchitis, or for an illness (≤8 days) in which cough is not the main symptom but PCP believes that acute bronchitis is the most likely diagnosis. Patients tested positive to COVID-19 who meet the above-mentioned criteria will be included too. Exclusion Criteria: Infection requiring antibiotic treatment (ex. cystic fibrosis) Pneumonia Known hypersensitivity to Pelargonium sidoides extract or excipients of the trial medication Non-infectious causes (COPD, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy) Lacking the faculty of discernment (for example: dementia, decompensated psychosis or severe depression) Inability to fill out the diary (no ability to read and understand French) Pregnancy or breastfeeding Immunological deficiencies Hospitalization Severe hepatic disease Patients who have already started a treatment with Pelargonium sidoides EPs® 7630 for this current episode (Kaloba®, Umckaloabo®) Important risk of bleeding (severe thrombocytopenia and anticoagulant intake) If the patient is taking a drug among these classes of drugs: anticoagulants, immunosuppressants, chemotherapy or immunotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The solution of Pelargonium sidoides extract EPs® 7630: 3x30 drops/day for 7 days and will be advised to pursue the treatment until the end of symptoms if bothered by the cough up to a maximum of 21 days. | Other: Pelargonium sidoides extract EPs® 7630<br>* Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).<br>|
| Active Comparator: Control group<br>Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy | Other: usual care<br>* symptomatic treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Pelargonium sidoides extract EPs® 7630 | Effectiveness will be determined by comparing the number of days needed to achieve a 50% reduction in the ABSS score after peak of symptoms in each group. | 22 days | 
| Proportion of patients taking antibiotics | The co-medication, including antibiotics, will be collected by the investigator at day 4, 8 and 22. The results will be compared between the two arms. | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration of a herbal medicinal product in conventional settings | Proportion of primary care physicians (PCPs) who agreed to participate in the study | 22 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelargonium sidoides