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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theranor s.p.r.l
ClinicalTrials.gov Identifier:
NCT01651715
First received: July 25, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Common Cold
Drug: TAO1, oral homeopathic antibodies
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Study Evaluating the Efficacy and Safety of Early Self-Treatment of Viral Upper Respiratory Tract Infections With Homeopathic Oral Antibodies to the TLR3 FYW Peptide (TAO1)

Resource links provided by NLM:


Further study details as provided by Theranor s.p.r.l:

Primary Outcome Measures:
  • Severity of symptoms of common cold [ Time Frame: Since start of symptoms of common cold up to the visit 3 (day 10-14) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Duration of common cold [ Time Frame: Since start of symptoms of common cold up to visit 3 (Day 10-14) ] [ Designated as safety issue: No ]
    Duration is defined as the number of days from self-reported onset of disease to the last day before the participant answered "Not sick" to the question, "How sick do you feel today?" (WURSS-21). A 2-day reduction in average disease duration versus placebo will be regarded as clinically significant.

  • Functional impairments in the course of the disease [ Time Frame: Since start of symptoms of common cold up to visit 3 (Day 10-14) ] [ Designated as safety issue: No ]
    Day-to-day scores for functional impairments domain. Overall (sum of all WURSS scores related to functional impairments over the follow-up).

  • The need of symptomatic analgesics/antipyretics [ Time Frame: Since start of symptoms of common cold up to visit 3 (Day 10-14) ] [ Designated as safety issue: Yes ]
    Patients will fill in diary cards on a daily basis. The following information will be recorded: study and patient identification, date of assessment, study medication intake, other medications (name, dose, frequency) and, AEs/SAEs (description)

  • Evaluation of safety [ Time Frame: since start of symptoms of common cold up to visit 3 (Day 10-14) ] [ Designated as safety issue: Yes ]
    Patients will fill in diary cards on a daily basis including AEs/SAEs reporting. Investigators will question patients at phone call and scheduled visits about AEs/SAEs. Frequency, severity, outcome and relationship to the study drug will be assessed.


Enrollment: 232
Study Start Date: September 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAO1, oral homeopathic antibodies
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

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 Comparator: Placebo
Same characteristics as investigational medicinal Product except for homeopathic dilutions of oral antibodies to the TLR3 FYW peptide
Drug: TAO1, oral homeopathic antibodies

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).


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651715

Locations
Belgium
Frank Heyvaert
Deurne, Antwerpen, Belgium, 2100
Hugo Loos
Geel, Antwerpen, Belgium, 2440
Christel Van Der Geer
Geel, Antwerpen, Belgium, 2440
Jan Joris
Mol, Antwerpen, Belgium, 2400
Jan De Jongh
Vorst, Antwerpen, Belgium, 2430
Jean-Pierre Devaux
Baisy-Thy, Brabant, Belgium, 1470
Virginie Risse
Bruxelles, Brabant, Belgium, 1180
Roel De Ryck
Kraainem, Brabant, Belgium, 1950
ResearchLink sprl
Linkebeek, Brabant, Belgium, 1630
Stéphane Vanden Bemden
Melsbroek, Brabant, Belgium, 1820
Bart Van Essche
Steenokkerzeel, Brabant, Belgium, 1820
Lode Vermeersch
Tremelo, Brabant, Belgium, 3120
Erik Schreurs
Tremelo, Brabant, Belgium, 3120
Luc De Munck
Vilvoorde, Brabant, Belgium, 1800
Patrice Lechien
Braine-le-Comte, Hainaut, Belgium, 7090
Charles Corbisier
Ecaussinnes, Hainaut, Belgium, 7190
Elise De Meulemeester
Gozée, Hainaut, Belgium, 6534
Magali Trefois
Gozée, Hainaut, Belgium, 6534
Philippe Jacques
Ham-sur-Heure Nalinnes, Hainaut, Belgium, 6120
Aubry Robert
Ham-sur-Heure Nalinnes, Hainaut, Belgium, 6120
Michel Grégoire
Pont-à-Celles, Hainaut, Belgium, 6230
Etienne Demanet
Thuin, Hainaut, Belgium, 6530
Maria Buscemi
Thuin, Hainaut, Belgium, 6530
Etienne Plees
Beringen, Limburg, Belgium, 3580
Nicole Olaerts
Ham, Limburg, Belgium, 3945
Paul Beke
Leopoldsburg, Limburg, Belgium, 3970
Steven Windmolders
Overpelt, Limburg, Belgium, 3900
Jos Weckx
Paal, Limburg, Belgium, 3583
Jan Behets
Paal, Limburg, Belgium, 3583
Herman Van Den Broeck
Tessenderlo, Limburg, Belgium, 3980
Yvan Calozet
Gribomont, Luxembourg, Belgium, 6887
Pierre-Henri Arnould
Libramont-Chevigny, Luxembourg, Belgium, 6800
Guy Van Damme
Heusden, Oost Vlaanderen, Belgium, 9070
Sponsors and Collaborators
Theranor s.p.r.l
Investigators
Principal Investigator: Stéphane Heijmans, MD RESEARCHLINK sprl
Study Director: Luc Moriau, PhD ECSOR sa/nv
Study Chair: Michel Thiry, PhD THERANOR sprl
  More Information

No publications provided

Responsible Party: Theranor s.p.r.l
ClinicalTrials.gov Identifier: NCT01651715     History of Changes
Other Study ID Numbers: ESTUAR001
Study First Received: July 25, 2012
Last Updated: August 5, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Common Cold
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014