Phytobronch: Management of Acute Bronchitis With Pelargonium Sidoides Extract

• Sponsor: University of Fribourg (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05916768
• Collaborator: (none)
• Enrollment: 412
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.5
• Patients Per Site Per Month: 26.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Bronchitis	Other: Pelargonium sidoides extract EPs® 7630; Other: usual care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 412 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs®7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial
• Actual Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: Aug 30, 2023
• Anticipated Study Completion Date: Aug 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Effectiveness of Pelargonium sidoides extract EPs® 7630 [22 days]

   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.

2. Proportion of patients taking antibiotics [22 days]

   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.

Secondary Outcome Measures

1. Integration of a herbal medicinal product in conventional settings [22 days]

   Proportion of primary care physicians (PCPs) who agreed to participate in the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Fribourg	Fribourg		Switzerland	1700

Sponsors and Collaborators

• University of Fribourg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Fribourg
• ClinicalTrials.gov Identifier: NCT05916768
• Other Study ID Numbers: 2023-00125
• First Posted: Jun 23, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Fribourg: pelargonium sidoides
• Additional relevant MeSH terms: Bronchitis; Acute Disease

Study Results

No Results Posted as of Jun 23, 2023