E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Viral upper respiratory tract infections |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022004 |
E.1.2 | Term | Influenza like illness |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010106 |
E.1.2 | Term | Common cold |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000938 |
E.1.2 | Term | Acute nasopharyngitis (common cold) |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046300 |
E.1.2 | Term | Upper respiratory infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of TAO1 in reducing the severity of symptoms of common cold in otherwise healthy adults |
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E.2.2 | Secondary objectives of the trial |
a) To evaluate the efficacy of TAO1 in reducing the duration of common cold
b) To evaluate the impact of TAO1 on health-related Quality of Life (functional impairment) in patients with common cold
c) To evaluate the safety of TAO1 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) Outpatients aged > or = 18 years
b) Ability and willingness to adhere to the study protocol
c) Signed informed consent
d) Self-reported recently emerged symptoms of common cold: answer "Yes" to the question "Do you believe that you are coming down with a cold?"
e) 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. |
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E.4 | Principal exclusion criteria |
a) Specific chronic diseases (autoimmune disease, chronic
bronchitis, human immunodeficiency virus (HIV) infection, lupus, rheumatoid arthritis)
b) Malignancy for which the patient has undergone resection, radiation or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
c) Cancer therapy
d) Immunosuppressant therapies
e) Use of systemic corticosteroids
f) A history of asthma or allergic rhinitis and corresponding symptoms (itchy eyes, sneezing, wheezing)
g) Any of the common cold symptoms persisting since more than 36 hours
h) Use of other homeopathic drugs designed to treat URTIs
i) Use of antibiotics, anti-histaminergic drugs or decongestants
j) Participation in another clinical trial within one month prior to treatment start
k) Previous participation (receipt of randomised treatment) in this study |
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E.5 End points |
E.5.1 | Primary end point(s) |
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 (of the sum of all WURSS scores over the
follow-up). A 30% reduction in AUC versus placebo will be regarded
as clinically significant |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
WURSS-21 questionnaire completed on a daily basis (minimum 10 days, maximum 14 days) upon contracting a common cold |
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E.5.2 | Secondary end point(s) |
a) Duration of common cold: 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?”. A 2-day reduction in average disease duration versus placebo will be regarded as clinically significant.
b) Functional impairments in the course of the disease:
- Day-to-day scores for functional impairments domain,
- Overall (sum of all WURSS scores related to functional impairments over the follow-up).
c) The need of symptomatic analgesics/antipyretics (average
number of intakes)
d) Evaluation of TAO1 safety: AEs and SAEs analysed in terms of frequency, severity, outcome and relationship to the study drug |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Daily basis (minimum 10 days, maximum 14 days) upon contracting a common cold |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 32 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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end of the trial = last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |