Management of acute bronchitis in Switzerland with an extract of Pelargonium sidoides EPs®7630 versus usual treatments – a pragmatic randomized controlled study.
Résumé de l'étude
This study aims to rigorously evaluate the effectiveness of Kaloba, a standardized extract of Pelargonium sidoides EPs7630, in the management of acute bronchitis in primary care practices in Romandy, Switzerland. Patients will be randomly assigned in a 1:1 ratio to receive the plant extract, Kaloba, or the treatment usually prescribed for this indication. They will be followed for 3 weeks. To this end, a healthcare professional will contact the patient by phone 3 times to assess their health status, the evolution of their symptoms, and their tolerance to the treatment. Additionally, the patient will be required to fill out a daily monitoring diary to record their symptoms and potential co-medications. Initially, a pilot study will assess the feasibility of the study on a sample of 40 patients. If the study proves feasible, 412 patients will be included in the RCT that will take place during the year 2023-2024. The following will be monitored: the effectiveness of the plant in reducing 1) the severity and 2) the duration of symptoms, 3) the proportion of patients receiving antibiotics. Furthermore, this study will also evaluate 4) the possible integration of this plant into a conventional healthcare system. This study allows for the evaluation of the effectiveness of a plant that, if the results are convincing, could offer a new effective treatment for managing patients suffering from this disease.
(BASEC)
Intervention étudiée
Kaloba is a medication based on an alcoholic plant extract that has market authorization in Switzerland. Since 1991, it has been recommended in the management of acute bronchitis in Europe [4].
To date, 12 randomized clinical studies have been conducted to evaluate the effectiveness of Kaloba® in the management of acute respiratory infections. According to these studies, Kaloba® appears to be beneficial in reducing the severity and duration of symptoms related to viral respiratory infections. The plant extract appears to be safe and well tolerated. However, due to the low quality of evidence and the heterogeneity of the data, further rigorous studies are needed to evaluate the effectiveness and safety of this extract.
(BASEC)
Maladie en cours d'investigation
Acute bronchitis
(BASEC)
- Age ≥ 18 years - First consultation in the context of this bronchial episode. Consultation - either for an acute cough (≤8 days) as the main symptom, suggesting acute bronchitis with or without COVID-19. - or for a disease (≤8 days) where cough is not the main symptom, but for which the treating physician considers acute bronchitis to be the most likely diagnosis. (BASEC)
Critères d'exclusion
• Infection requiring antibiotic treatment (e.g.: cystic fibrosis) • Pneumonia • Non-infectious cause of cough (COPD, asthma, pulmonary embolism, heart failure, gastroesophageal reflux, allergy) • Inability to discern (e.g. in the context of dementia, decompensated psychosis, or severe depression) • Inability to fill out the diary • Pregnancy or breastfeeding • Significant risk of bleeding (severe thrombocytopenia, use of oral anticoagulants) • Immunological deficiency • Severe liver disease • Use of anticoagulants, immunosuppressants, and/or chemotherapy/immunotherapy • Symptoms of acute bronchitis for more than 8 days. • Known hypersensitivity to any of the components of the medication • Use of Kaloba or Umckaloabo in the 2 days prior to treat this episode of acute bronchitis. (BASEC)
Lieu de l’étude
Fribourg, Genève, Lausanne, Neuchâtel, Sion, Autre
(BASEC)
Jura
(BASEC)
Sponsor
University of Fribourg
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Pierre-Yves Rodondi
+41 26 300 94 44
pierre-yves.rodondi@clutterunifr.chInstitut de médecine de famille, Université de Fribourg
(BASEC)
Informations générales
University of Fribourg
(ICTRP)
Informations scientifiques
University of Fribourg
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
09.05.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05916768 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Management of acute bronchitis in Switzerland with Pelargonium sidoides extract EPS®7630 versus usual care – a pragmatic, open-label, randomised controlled trial (BASEC)
Titre académique
Management of Acute Bronchitis in Switzerland With Pelargonium Sidoides Extract EPs7630 Versus Usual Care - a Pragmatic, Open-label, Randomised Controlled Trial (ICTRP)
Titre public
Management of Acute Bronchitis With Pelargonium Sidoides Extract (ICTRP)
Maladie en cours d'investigation
Acute Bronchitis (ICTRP)
Intervention étudiée
Other: Pelargonium sidoides extract EPs 7630Other: usual care (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Effectiveness of Pelargonium sidoides extract EPs� 7630;Proportion of patients taking antibiotics (ICTRP)
Integration of a herbal medicinal product in conventional settings (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Pierre-Yves Rodondi, Prof., University of Fribourg (ICTRP)
ID secondaires
2023-00125 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05916768 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible