Clinical trial NCT05916768: Management of Acute Bronchitis With Pelargonium Sidoides Extract
Official title: Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acute Bronchitis
Keywords: pelargonium sidoides
Lead sponsor: University of Fribourg
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of Pelargonium sidoides extract EPs® 7630
timeFrame: 22 days
measure: Proportion of patients taking antibiotics
timeFrame: 22 days
Secondary outcomes:
measure: Integration of a herbal medicinal product in conventional settings
timeFrame: 22 days
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: University of Fribourg
Study officials:
affiliation: University of Fribourg
name: Pierre-Yves Rodondi, Prof.
role: PRINCIPAL_INVESTIGATOR
References: