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

NCT ID: NCT03812900

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2019-06-07

Brief 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.

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.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Formulation A

Echinacea purpurea alcoholic extract lozenges (novel formulation)

Group Type: EXPERIMENTAL

Echinacea purpurea alcoholic extract

Intervention Type: DRUG

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

Formulation B

Echinacea purpurea alcoholic extract spray (novel formulation)

Group Type: EXPERIMENTAL

Echinacea purpurea alcoholic extract

Intervention Type: DRUG

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

Formulation C

Echinacea purpurea alcoholic extract tablet (basic formulation, reference)

Group Type: ACTIVE_COMPARATOR

Echinacea purpurea alcoholic extract

Intervention Type: DRUG

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

Formulation D

Echinacea purpurea alcoholic extract, drops (basic formulation, reference)

Group Type: ACTIVE_COMPARATOR

Echinacea purpurea alcoholic extract

Intervention Type: DRUG

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

Interventions

Echinacea purpurea alcoholic extract

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: collaborator

Labormedizinisches Zentrum Dr. Risch

INDUSTRY

Sponsor Role: collaborator

A. Vogel AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cantonal Hospital St. Gallen

Sankt Gallen, , Switzerland

Countries

Switzerland

References

Sumer J, Keckeis K, Scanferla G, Frischknecht M, Notter J, Steffen A, Kohler P, Schmid P, Roth B, Wissel K, Vernazza P, Klein P, Schoop R, Albrich WC. Novel Echinacea formulations for the treatment of acute respiratory tract infections in adults-A randomized blinded controlled trial. Front Med (Lausanne). 2023 Apr 17;10:948787. doi: 10.3389/fmed.2023.948787. eCollection 2023.

Reference Type: DERIVED

PMID: 37138742 (View on PubMed)

Other Identifiers

5'000'155

Identifier Type: -

Identifier Source: org_study_id