Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections

NCT01651715 | Completed Phase 1

• 1 other identifier: ESTUAR001
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 33

Brief Summary

The purpose of this study is to determine whether early self-treatment with homeopathic dilutions of oral antibodies to a key-protein of the immune system are effective and safe in the treatment of viral upper respiratory tract infections

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• Severity of symptoms of common cold

  Decrease in severity is assessed as reduction in average area under the curve (AUC) under the time severity curve (sum of all WURSS scores over the follow-up). The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) is a validated tool to evaluate the duration and severity of common cold. It is constituted of twenty-one categorical questions (Likert-type 7-level severity scale).

  Since start of symptoms of common cold up to the visit 3 (day 10-14)

Secondary Outcomes (4)

• Duration of common cold

  Since start of symptoms of common cold up to visit 3 (Day 10-14)

• Functional impairments in the course of the disease

  Since start of symptoms of common cold up to visit 3 (Day 10-14)

• The need of symptomatic analgesics/antipyretics

  Since start of symptoms of common cold up to visit 3 (Day 10-14)

• Evaluation of safety

  since start of symptoms of common cold up to visit 3 (Day 10-14)

Study Arms (2)

TAO1, oral homeopathic antibodies

EXPERIMENTAL

TAO1 is an investigational medicinal product containing homeopathic dilutions (\<10-24M) of antibodies purified from the serum of rabbit immunised against a synthetic peptide with an amino acid sequence selected in the human toll-like receptor type 3 sequence (anti-TLR3). It is intended for the treatment of viral Upper Respiratory Tract Infections (URTIs) such as common cold, influenza or influenza-like illnesses.

Drug: TAO1, oral homeopathic antibodies

Placebo

PLACEBO COMPARATOR

Same characteristics as investigational medicinal Product except for homeopathic dilutions of oral antibodies to the TLR3 FYW peptide

Drug: TAO1, oral homeopathic antibodies

Interventions

TAO1, oral homeopathic antibodies DRUG

TAO1 comprises a mixture of homeopathic dilutions C12+C30+C200 (drug product is made by impregnation of pre-made tablets). The investigational product will be taken for 7 days as follow: Day 1: 3 tablets over the first 2 hours of treatment, then 3 tablets over the rest of Day 1. Days 2-3: 5 tablets/day (intakes distributed evenly over the daytime). Days 4-7: 3 tablets/day (intakes distributed evenly over the daytime).

Placebo; TAO1, oral homeopathic antibodies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients aged \> or = 18 years
• Ability and willingness to adhere to the study protocol
• Signed informed consent
• Self-reported recently emerged symptoms of common cold: answer "Yes" to the question "Do you believe that you are coming down with a cold?"
• At least one of the following 4 common cold symptoms: sneezing, runny nose, nasal obstruction and/or sore throat, with no limitations of symptom severity.

You may not qualify if:

• Specific chronic diseases (autoimmune disease, chronic bronchitis, human immunodeficiency virus (HIV) infection, lupus, rheumatoid arthritis)
• Malignancy for which the patient has undergone resection, radiation or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
• Cancer therapy
• Immunosuppressant therapies
• Use of systemic corticosteroids
• A history of asthma or allergic rhinitis and corresponding symptoms (itchy eyes, sneezing, wheezing)
• Any of the common cold symptoms persisting since more than 36 hours
• Use of other homeopathic drugs designed to treat URTIs
• Use of antibiotics, anti-histaminergic drugs or decongestants
• Participation in another clinical trial within one month prior to treatment start
• Previous participation (receipt of randomised treatment) in this study

Sponsors & Collaborators

• Theranor s.p.r.l: lead

Study Sites (33)

Frank Heyvaert

Deurne, Antwerpen, 2100, Belgium

Location

Christel Van Der Geer

Geel, Antwerpen, 2440, Belgium

Location

Hugo Loos

Geel, Antwerpen, 2440, Belgium

Location

Jan Joris

Mol, Antwerpen, 2400, Belgium

Location

Jan De Jongh

Vorst, Antwerpen, 2430, Belgium

Location

Jean-Pierre Devaux

Baisy-Thy, Brabant, 1470, Belgium

Location

Virginie Risse

Brussels, Brabant, 1180, Belgium

Location

Roel De Ryck

Kraainem, Brabant, 1950, Belgium

Location

ResearchLink sprl

Linkebeek, Brabant, 1630, Belgium

Location

Stéphane Vanden Bemden

Melsbroek, Brabant, 1820, Belgium

Location

Bart Van Essche

Steenokkerzeel, Brabant, 1820, Belgium

Location

Erik Schreurs

Tremelo, Brabant, 3120, Belgium

Location

Lode Vermeersch

Tremelo, Brabant, 3120, Belgium

Location

Luc De Munck

Vilvoorde, Brabant, 1800, Belgium

Location

Patrice Lechien

Braine-le-Comte, Hainaut, 7090, Belgium

Location

Charles Corbisier

Ecaussinnes, Hainaut, 7190, Belgium

Location

Elise De Meulemeester

Gozée, Hainaut, 6534, Belgium

Location

Magali Trefois

Gozée, Hainaut, 6534, Belgium

Location

Aubry Robert

Ham-sur-Heure-Nalinnes, Hainaut, 6120, Belgium

Location

Philippe Jacques

Ham-sur-Heure-Nalinnes, Hainaut, 6120, Belgium

Location

Michel Grégoire

Pont-à-Celles, Hainaut, 6230, Belgium

Location

Etienne Demanet

Thuin, Hainaut, 6530, Belgium

Location

Maria Buscemi

Thuin, Hainaut, 6530, Belgium

Location

Etienne Plees

Beringen, Limburg, 3580, Belgium

Location

Nicole Olaerts

Ham, Limburg, 3945, Belgium

Location

Paul Beke

Leopoldsburg, Limburg, 3970, Belgium

Location

Steven Windmolders

Overpelt, Limburg, 3900, Belgium

Location

Jan Behets

Paal, Limburg, 3583, Belgium

Location

Jos Weckx

Paal, Limburg, 3583, Belgium

Location

Herman Van Den Broeck

Tessenderlo, Limburg, 3980, Belgium

Location

Yvan Calozet

Gribomont, Luxembourg, 6887, Belgium

Location

Pierre-Henri Arnould

Libramont-Chevigny, Luxembourg, 6800, Belgium

Location

Guy Van Damme

Heusden, Oost Vlaanderen, 9070, Belgium

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Stéphane Heijmans, MD

  RESEARCHLINK sprl

  PRINCIPAL INVESTIGATOR

• Luc Moriau, PhD

  ECSOR sa/nv

  STUDY DIRECTOR

• Michel Thiry, PhD

  THERANOR sprl

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

BE (33)