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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Drug: Echinacea purpurea alcoholic extract


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br>Echinacea purpurea alcoholic extract lozenges (novel formulation) | Drug: Echinacea purpurea alcoholic extract<br>* Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)<br>|
| Experimental: Formulation B<br>Echinacea purpurea alcoholic extract spray (novel formulation) | Drug: Echinacea purpurea alcoholic extract<br>* Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)<br>|
| Active Comparator: Formulation C<br>Echinacea purpurea alcoholic extract tablet (basic formulation, reference) | Drug: Echinacea purpurea alcoholic extract<br>* Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)<br>|
| Active Comparator: Formulation D<br>Echinacea purpurea alcoholic extract, drops (basic formulation, reference) | Drug: Echinacea purpurea alcoholic extract<br>* Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to remission from initial episodes | duration until respiratory symptoms are solved | maximally 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to remission from overall episodes | duration until respiratory symptoms are solved | maximally 10 days | 
| Cross-comparison of remissions between formulations | duration until respiratory symptoms are solved | maximally 10 days | 
| Development of single respiratory symptoms | Comparison of respiratory symptom scores between formulations, adapted Jackson Score [0-3, 0=absent, 3=severe] | maximally 10 days | 
| 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 | 
| Absence from School/Work | Number of days absent from work or school | during acute respiratory episodes, 7 days each | 
| 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 | 
| 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 | 
| 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 | 
| Blood safety (creatinin [umol/l]) | Change of blood parameters before (V1) and after treatment (V2) | At Inclusion visit and day 5 of infection | 
| Blood safety (ALT [ukat/l]) | Change of blood parameters before (V1) and after treatment (V2) | At Inclusion visit and day 5 of infection | 
| Blood safety (AST [ukat/l]) | Change of blood parameters before (V1) and after treatment (V2) | At Inclusion visit and day 5 of infection | 
| Blood safety (Bilirubin [umol/l]) | Change of blood parameters before (V1) and after treatment (V2) | At Inclusion visit and day 5 of infection | 
| Acceptance of treatment | Question:would you use the medicament again? | At end of treatment cycle of 10 days | 
| Concomitant medication and -therapy | Incidence of concomitant medication and -therapy | during acute respiratory episodes of 10 days | 
| adverse events | occurrence of adverse events during treatment with Echinacea | during acute respiratory episodes, from day 1 until follow up at day 17 - 21 | 
| 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 |