Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Respiratory Tract Infections

Respiratory Tract Infections Clinical Trial

Official title:

Comparative, Conceptual, Randomized Clinical Study to Investigate Superiority of Newly Developed Over Basic Echinacea Formulations for the Treatment of Acute Symptoms of Respiratory Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812900
• Other study ID #: 5'000'155
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 27, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: April 2021
• Source: Bioforce AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a comparative, conceptual, randomized clinical study to investigate newly developed over basic Echinacea formulations for the treatment of acute symptoms of respiratory tract infections. 400 adults will be recruited, of which approximately 300 will develop a common cold or a influenza-like infection. Two newly developed and two existing Echinacea formulations (solid/liquid) will be randomly dispensed at inclusion for treatment of maximal 3 infections. Treatment starts at first signs of infection and lasts for a maximum of 10 days or until symptom resolution. Nasopharynx samples will be collected for analysis of common viral respiratory agents throughout treatment. Safety and efficacy variables will be assessed.

Description:

The monocentre trial compares two newly developed pharmaceutical forms of Echinacea (extract from Echinacea purpurea Herba and Radix; lozenges or spray) with two basic and authorised pharmaceutical forms (tablets or drops; comparator groups) for the treatment of acute symptoms of the common cold and/or influenza-like illness (ILI) in adults. Trial subjects are preventatively screened and included in the study (n = 400). If they show acute symptoms of a common cold or ILI during the study period, they are instructed to call the study centre to have confirmed the indication for treatment and begin with the treatment, they are randomized to (1:1:1:1 randomization into one of four groups). The primary endpoint is the time until remission of respiratory symptoms with the new pharmaceutical forms compared to the basic forms during the first episode. Secondary endpoints include remission of all treated episodes (max. 3 episodes), remission times comparison between different pharmaceutical forms (e.g. lozenges vs. spray, lozenges vs. drops etc), reduction of viral load on day 5 and 9 compared to day 1 of treatment (nasopharyngeal swabs), differences in safety (blood parameters before and during treatment), differences in number of adverse events, tolerance and efficacy assessed by the patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: June 7, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years old
• Signed Informed Consent

Exclusion Criteria:

• Younger than 18 years
• Participation in another clinical study in the past 30 days
• Permanent intake of antimicrobial, antiviral, immune suppressive substances
• Surgical intervention in the 3 months prior to inclusion or planned surgery during period of observation
• Known diabetes melitus
• Known and treated atopy or asthma bronchiale
• Cystic fibrosis, bronchopulmonale dysplasia, COPD
• Known diseases of the immune system, degenerative illnesses (e.g. auto-immune disorders like AIDS or leukemia, myeloma)
• Known metabolic or resorptive disorders
• Known chronic liver diseases (chronic hepatitis, liver cirrhosis)
• Known chronic kidney insufficiency
• Serious health issues (reduced health status, autoimmune illness, tumorous illness)
• Known allergy to plants of compositae family (camomille, dandelion) or to any substances of the investigational product
• At inclusion known pregnancy or planned pregnancy during period of investigation (required: active contraception for women of childbearing year)

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• Echinacea purpurea alcoholic extract
Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital St. Gallen	Saint Gallen

Sponsors (3)

Lead Sponsor	Collaborator
Bioforce AG	Cantonal Hospital of St. Gallen, Labormedizinisches Zentrum Dr. Risch

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to remission from initial episodes	duration until respiratory symptoms are solved	maximally 10 days
Secondary	Time to remission from overall episodes	duration until respiratory symptoms are solved	maximally 10 days
Secondary	Cross-comparison of remissions between formulations	duration until respiratory symptoms are solved	maximally 10 days
Secondary	Development of single respiratory symptoms	Comparison of respiratory symptom scores between formulations, adapted Jackson Score [0-3, 0=absent, 3=severe]	maximally 10 days
Secondary	Development of respiratory symptom sum score	Comparison of symptom sum scores between formulations, adapted Jackson Score [0-27, each 0=absent, 3=severe]	maximally 10 days
Secondary	Absence from School/Work	Number of days absent from work or school	during acute respiratory episodes, 7 days each
Secondary	Reduction of viral load in nasopharyngeal samples	Comparison of virus titer at day 5 and 9 i.c. to day 1	day 1, day 5, day 9
Secondary	Subjective assessment of efficacy by patient	Comparisons of subjective efficacy assessments between patients [0=poor; 1=moderate; 2=good; 3=very good]. Inofficial scale and and global method of assessing patients satisfaction re efficacy.	At end of treatment cycle of 10 days
Secondary	Blood safety (red and white cell count)	Change of blood parameters before (V1) and after treatment (V2)	At Inclusion visit and day 5 of infection
Secondary	Blood safety (creatinin [umol/l])	Change of blood parameters before (V1) and after treatment (V2)	At Inclusion visit and day 5 of infection
Secondary	Blood safety (ALT [ukat/l])	Change of blood parameters before (V1) and after treatment (V2)	At Inclusion visit and day 5 of infection
Secondary	Blood safety (AST [ukat/l])	Change of blood parameters before (V1) and after treatment (V2)	At Inclusion visit and day 5 of infection
Secondary	Blood safety (Bilirubin [umol/l])	Change of blood parameters before (V1) and after treatment (V2)	At Inclusion visit and day 5 of infection
Secondary	Acceptance of treatment	Question:"would you use the medicament again?"	At end of treatment cycle of 10 days
Secondary	Concomitant medication and -therapy	Incidence of concomitant medication and -therapy	during acute respiratory episodes of 10 days
Secondary	adverse events	occurrence of adverse events during treatment with Echinacea	during acute respiratory episodes, from day 1 until follow up at day 17 - 21
Secondary	Subjective assessment of tolerability by patient	Comparisons of subjective tolerability assessments between patients [0=poor; 1=moderate; 2=good; 3=very good]. Inofficial scale and and global method of assessing patients satisfaction re tolerability.	At day 10 of every treatment cycle