- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01944631
Iota-Carrageenan Nasal Spray in Common Cold
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Cardiff, United Kingdom
- 1326.1.44001 Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Nasal spray 4 times a day over 4 to 10 days
|
Nasal spray saline
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Experimental: Iota-Carrageenan nasal spray
Nasal spray 4 times a day over 4 to 10 days
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Nasal spray containing 1.20 g/l Iota-Carrageenan in saline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)
Time Frame: Days 2, 3 and 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
|
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)
Time Frame: Days 2, 3 and 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). |
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)
Time Frame: Days 2, 3 and 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)
Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 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
Time Frame: Baseline up to 10 days
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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
Time Frame: Day 10
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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
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1326.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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