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Management of Acute Bronchitis With Pelargonium Sidoides Extract (Phytobronch)

Primary Purpose

Acute Bronchitis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Pelargonium sidoides extract EPs® 7630
usual care
Sponsored by
University of Fribourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchitis focused on measuring pelargonium sidoides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Fribourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Integration of a herbal medicinal product in conventional settings
Proportion of primary care physicians (PCPs) who agreed to participate in the study

Full Information

First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
University of Fribourg
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1. Study Identification

Unique Protocol Identification Number
NCT05916768
Brief Title
Management of Acute Bronchitis With Pelargonium Sidoides Extract
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Fribourg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis
Keywords
pelargonium sidoides

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Usual care. Reference therapies, which are classified as symptomatic treatments, are chosen freely by the PCP except for phytotherapy
Intervention Type
Other
Intervention Name(s)
Pelargonium sidoides extract EPs® 7630
Intervention Description
Kaloba® solution, a standardized alcoholic extract obtained from the roots of Pelargonium sidoides (EPs® 7630).
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
symptomatic treatments
Primary Outcome Measure Information:
Title
Effectiveness of Pelargonium sidoides extract EPs® 7630
Description
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.
Time Frame
22 days
Title
Proportion of patients taking antibiotics
Description
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.
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Integration of a herbal medicinal product in conventional settings
Description
Proportion of primary care physicians (PCPs) who agreed to participate in the study
Time Frame
22 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves Rodondi, Prof.
Organizational Affiliation
University of Fribourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Fribourg
City
Fribourg
ZIP/Postal Code
1700
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
anonymised database, only for patients who signed the consent statement for the re-use of data in coded form.

Learn more about this trial

Management of Acute Bronchitis With Pelargonium Sidoides Extract

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