Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections (ESTUAR)
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| ClinicalTrials.gov Identifier: NCT01651715 |
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Recruitment Status :
Completed
First Posted : July 27, 2012
Last Update Posted : August 7, 2013
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Sponsor:
Theranor s.p.r.l
Information provided by (Responsible Party):
Theranor s.p.r.l
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Common Cold | Drug: TAO1, oral homeopathic antibodies | Phase 1 Phase 2 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 232 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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) |
| Study Start Date : | September 2012 |
| Actual Primary Completion Date : | August 2013 |
| Actual Study Completion Date : | August 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Common Cold
Drug Information available for:
Globulin, Immune
| Arm | Intervention/treatment |
|---|---|
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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.
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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). |
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Placebo Comparator: Placebo
Same characteristics as investigational medicinal Product except for homeopathic dilutions of oral antibodies to the TLR3 FYW peptide
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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). |
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) ]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) ]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) ]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) ]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) ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651715
Locations
| Belgium | |
| Frank Heyvaert | |
| Deurne, Antwerpen, Belgium, 2100 | |
| Christel Van Der Geer | |
| Geel, Antwerpen, Belgium, 2440 | |
| Hugo Loos | |
| 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 | |
| Erik Schreurs | |
| Tremelo, Brabant, Belgium, 3120 | |
| Lode Vermeersch | |
| 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 | |
| Aubry Robert | |
| Ham-sur-Heure Nalinnes, Hainaut, Belgium, 6120 | |
| Philippe Jacques | |
| 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 | |
| Jan Behets | |
| Paal, Limburg, Belgium, 3583 | |
| Jos Weckx | |
| 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 |
| Responsible Party: | Theranor s.p.r.l |
| ClinicalTrials.gov Identifier: | NCT01651715 History of Changes |
| Other Study ID Numbers: |
ESTUAR001 |
| First Posted: | July 27, 2012 Key Record Dates |
| Last Update Posted: | August 7, 2013 |
| Last Verified: | August 2013 |
Additional relevant MeSH terms:
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Respiratory Tract Infections Common Cold Infection Respiratory Tract Diseases Picornaviridae Infections RNA Virus Infections |
Virus Diseases Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs |