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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Drug: Echinacea purpurea alcoholic extract

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Saint Gallen, Switzerland
    • Cantonal Hospital St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: A. Vogel AG
• Collaborators: Cantonal Hospital of St. Gallen; Labormedizinisches Zentrum Dr. Risch

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 7, 2019

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 5'000'155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No