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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Nasal spray 4 times a day over 4 to 10 days |
|
| Iota-Carrageenan nasal spray | Experimental | Nasal spray 4 times a day over 4 to 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Device | Nasal spray saline |
| |
| Iota-Carrageenan |
| 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:
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 |
| 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:
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). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1326.1.44001 Boehringer Ingelheim Investigational Site | Cardiff | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26438038 | Derived | Eccles R, Winther B, Johnston SL, Robinson P, Trampisch M, Koelsch S. Efficacy and safety of iota-carrageenan nasal spray versus placebo in early treatment of the common cold in adults: the ICICC trial. Respir Res. 2015 Oct 5;16:121. doi: 10.1186/s12931-015-0281-8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril. |
| FG001 | Bisolviral | Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set which included all randomised patients who used at least one dose of trial treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril. |
| BG001 | Bisolviral | Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
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). | Full analysis set (FAS) which included all randomised patients who used at least one dose of trial treatment, who provided a baseline total symptom score (TSS) as well as any post-treatment data for the primary endpoint. | Posted | Least Squares Mean | Standard Error | units on a scale | Days 2, 3 and 4 |
|
From first nasal spray administration until the application discontinuation date plus one day, up to 11 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| Device |
Nasal spray containing 1.20 g/l Iota-Carrageenan in saline |
|
| 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:
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:
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 |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Placebo | Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril. |
| OG001 | Bisolviral | Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril. |
|
|
|
| Secondary | 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:
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). | FAS | Posted | Least Squares Mean | Standard Error | units on a scale | Days 2, 3 and 4 |
|
|
|
|
| Secondary | 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:
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). | FAS | Posted | Least Squares Mean | Standard Error | units on a scale | Days 2, 3 and 4 |
|
|
|
|
| Secondary | 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:
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). | FAS | Posted | Least Squares Mean | Standard Error | units on a scale * days | Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 |
|
|
|
|
| Secondary | 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. | FAS | Posted | Median | 95% Confidence Interval | days | Baseline up to 10 days |
|
|
|
|
| Secondary | 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). | FAS | Posted | Number | percentage of participants | Day 10 |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Bisolviral | Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril. | 0 | 100 | 0 | 100 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Good |
|
| Fair |
|
| Poor |
|