Management of Acute Bronchitis With Pelargonium Sidoides Extract (Phytobronch)

University of Fribourg

Status: Invitation-only

Conditions: Acute Bronchitis

Treatments: Other: usual care; Other: Pelargonium sidoides extract EPs® 7630

Study type: Interventional

Funder types: Other

Identifiers

NCT05916768

2023-00125

Details and patient eligibility

About

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.

Full 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).

Enrollment: 412 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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412 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Pelargonium sidoides extract EPs® 7630

Control group

Active Comparator group

Description:

Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy

Treatment:

Other: usual care