Management of Acute Bronchitis With Pelargonium Sidoides Extract

Acute Bronchitis Clinical Trial

— Phytobronch  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05916768
• Other study ID #: 2023-00125
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2023
• Source: University of Fribourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 412
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Disease
• Bronchitis

Intervention

Other:
• Pelargonium sidoides extract EPs® 7630
Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).
• usual care
symptomatic treatments

Locations

Country	Name	City	State
Switzerland	University of Fribourg	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
University of Fribourg

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Integration of a herbal medicinal product in conventional settings	Proportion of primary care physicians (PCPs) who agreed to participate in the study	22 days