Iota-Carrageenan Nasal Spray in Common Cold

Phase 4

Completed

• Conditions: Common Cold
• Interventions: Device: Placebo; Device: Iota-Carrageenan

• Registration Number: NCT01944631
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-17
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2015-02-27
• Status Verified: 2015-03
• Results First Submitted QC: 2015-04-02
• Last Update Submitted: 2015-04-02
• Results First Posted: 2015-04-03
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Nasal spray 4 times a day over 4 to 10 days
Iota-Carrageenan nasal spray	Iota-Carrageenan	Nasal spray 4 times a day over 4 to 10 days

Primary Outcome Measures

Name	Time	Method
Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)	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: * 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

Name	Time	Method
Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)	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: * 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)	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: * 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)	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: * 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	Baseline up to 10 days	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	Day 10	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).

Trial Locations

Locations (1)

1326.1.44001 Boehringer Ingelheim Investigational Site; 🇬🇧 Cardiff, United Kingdom