Iota-Carrageenan Nasal Spray in Common Cold

Study Overview
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Brief Summary
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The aim of this clinical trial is to investigate the effect of Iota-Carrageenan treatment on cold symptoms. The effect of treatment on the duration of the cold and the patients viral load plus cytokine level indicating the inflammatory response will be analyzed.

Official Title
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Efficacy and Safety of Iota-Carrageenan Nasal Spray 1.2 g/l (0.12 Percent) (Bisolviral) Versus Placebo Nasal Spray in the Early Treatment of Common Cold

Conditions
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Common Cold

Intervention / Treatment
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* Device: Placebo
* Device: Iota-Carrageenan


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients consider that they are in an early stage of common cold with symptoms of no more than 48 hours duration Symptom score of equal or more than 1 for for at least one of the symptoms sore throat, runny nose and blocked nose on a 0-3 verbal rating scale Total symptom score of equal or less 9 for symptoms headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough, and sneezing measured on a 0-3 verbal rating scale Patients agree to refrain from taking any products intended to prevent, intervene in, or treat cough/colds/flu, starting at study entry and continuing through day 10 (e.g. those containing zinc, Echinacea); use of a daily multivitamin is allowed. Exclusion criteria: Known hypersensitivity or are allergic to any component of the test device Clinically significant cardiovascular, endocrinological, neurological, respiratory, gastrointestinal disease or history or any current disease that is considered by the investigator as a reason for exclusion e.g. current allergic rhinitis, chronic obstructive pulmonary disease Severe nasal septum deviation or other condition that could cause nasal obstruction such as the presence of nasal polyps. History of nasal or sinus surgery that in the opinion of the investigator may influence symptom scores Taking any prescribed medication other than for contraception, that is considered by the investigator as a reason for exclusion e.g. systemic steroids, intranasal medicines, antibiotics Common cold or flu like symptoms for more than 48 hours. Recent (within the previous 2 days) intake of a common cold medicine that in the opinion of the investigator may influence symptom scores (analgesics, nasal decongestants, cough medicines) Current smoker (more than 10 cigarettes a day)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Nasal spray 4 times a day over 4 to 10 days | Device: Placebo<br>* Nasal spray saline<br>|
| Experimental: Iota-Carrageenan nasal spray<br>Nasal spray 4 times a day over 4 to 10 days | Device: Iota-Carrageenan<br>* Nasal spray containing 1.20 g/l Iota-Carrageenan in saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) | The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms. Each common cold symptom was scored on a 4-point ordinal scale: 0 = symptom not present 1 = mild symptom (I can feel it but it has not disturbed or irritated me) 2 = moderate symptom (symptom has disturbed and irritated me some of the time) 3 = severe symptom (symptom has disturbed and irritated me most of the time) The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms). | Days 2, 3 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4) | The mean of the sum of 3 single systemic common cold symptom scores (headache, muscle ache, chilliness). Each common cold symptom was scored on a 4-point ordinal scale: 0 = symptom not present 1 = mild symptom (I can feel it but it has not disturbed or irritated me) 2 = moderate symptom (symptom has disturbed and irritated me some of the time) 3 = severe symptom (symptom has disturbed and irritated me most of the time) The mean of the sum of 3 single systemic common cold symptom scores over days 2-4 was calculated as (SSS2 + SSS3 + SSS4)/3 where SSS2, SSS3 and SSS4 are the systemic common cold symptom scores calculated for days 2, 3 and 4 respectively. SSS2-4 ranges from 0 (no symptoms) to 9 (severe symptoms). | Days 2, 3 and 4 | 
| Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4) | The mean of the sum of 5 single local common cold symptom scores (sore throat, blocked nose, runny nose, cough and sneezing). Each common cold symptom was scored on a 4-point ordinal scale: 0 = symptom not present 1 = mild symptom (I can feel it but it has not disturbed or irritated me) 2 = moderate symptom (symptom has disturbed and irritated me some of the time) 3 = severe symptom (symptom has disturbed and irritated me most of the time) The mean of the sum of 5 single local common cold symptom scores over days 2 to 4 was calculated as (LSS2 + LSS3 + LSS4)/3 where LSS2, LSS3 and LSS4 are the local common cold symptom scores calculated for days 2, 3 and 4 respectively. LSS2-4 ranges from 0 (no symptoms) to 15 (severe symptoms). | Days 2, 3 and 4 | 
| Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10) | The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms. Each common cold symptom was scored on a 4-point ordinal scale: 0 = symptom not present 1 = mild symptom (I can feel it but it has not disturbed or irritated me) 2 = moderate symptom (symptom has disturbed and irritated me some of the time) 3 = severe symptom (symptom has disturbed and irritated me most of the time) The Area under the curve (AUC) over the 10-day period for the total symptom score (AUC-TSS 1-10) was calculated as the sum of the TSS calculated on each day from day 1 to day 10. AUC-TSS 1-10 ranges from 0 (no symptoms) to 270 (severe symptoms). | Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 | 
| Duration of the Cold | Duration of the common cold was assessed by the question Do you still have a cold? at the end of each treatment day. The duration of the cold was defined as ended by the first day of a No answer to this daily question. | Baseline up to 10 days | 
| Patient Overall Assessment of Efficacy | Patient overall assessment of efficacy was assessed by the question How effective was the treatment in relieving your common cold symptoms? at day 10. A 5-point scale was used (0=poor, 1=fair, 2=good, 3=very good, 4=excellent). | Day 10 |