Back to resultsIota-Carrageenan Nasal Spray in Common Cold
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Iota-Carrageenan
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold
Eligibility Criteria
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)
Sites / Locations
- 1326.1.44001 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Iota-Carrageenan nasal spray
Arm Description
Nasal spray 4 times a day over 4 to 10 days
Nasal spray 4 times a day over 4 to 10 days
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01944631
Brief Title
Iota-Carrageenan Nasal Spray in Common Cold
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nasal spray 4 times a day over 4 to 10 days
Arm Title
Iota-Carrageenan nasal spray
Arm Type
Experimental
Arm Description
Nasal spray 4 times a day over 4 to 10 days
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Nasal spray saline
Intervention Type
Device
Intervention Name(s)
Iota-Carrageenan
Intervention Description
Nasal spray containing 1.20 g/l Iota-Carrageenan in saline
Primary Outcome Measure Information:
Title
Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)
Description
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).
Time Frame
Days 2, 3 and 4
Secondary Outcome Measure Information:
Title
Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)
Description
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).
Time Frame
Days 2, 3 and 4
Title
Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)
Description
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).
Time Frame
Days 2, 3 and 4
Title
Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)
Description
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).
Time Frame
Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Title
Duration of the Cold
Description
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.
Time Frame
Baseline up to 10 days
Title
Patient Overall Assessment of Efficacy
Description
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).
Time Frame
Day 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1326.1.44001 Boehringer Ingelheim Investigational Site
City
Cardiff
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26438038
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
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Iota-Carrageenan Nasal Spray in Common Cold
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