Management of Acute Bronchitis With Pelargonium Sidoides Extract (Phytobronch)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Bronchitis
• Intervention / Treatment: Other: Pelargonium sidoides extract EPs® 7630; Other: usual care

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Fribourg
    • Fribourg, Canton of Fribourg, Switzerland, 1700
      • University of Fribourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).
Active Comparator: Control group; Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy	Other: usual care; symptomatic treatments

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Fribourg
• Investigators: Principal Investigator: Pierre-Yves Rodondi, Prof., University of Fribourg

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): April 24, 2025

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pelargonium sidoides
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis
• Other Study ID Numbers: 2023-00125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: anonymised database, only for patients who signed the consent statement for the re-use of data in coded form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No