Clinical Trial: Iota-Carrageenan Nasal Spray in Common Cold

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) [ Time Frame: Days 2, 3 and 4 ]

Original Primary Outcome: Total symptom score (TSS) of the 8 single common cold symptom scores (headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, cough and sneezing), mean over days 2 to 4 (TSS2-4) [ Time Frame: Day 2 to day 4 ]

Current Secondary Outcome:

• 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:

  • 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) [ 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:

  • 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) [ 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:

  • 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 [ Time Frame: 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 [ Time Frame: 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).

Original Secondary Outcome:

• Sum of 3 single systemic common cold symptom scores (headache, muscle ache, chilliness), mean over days 2 to 4 [ Time Frame: Day 2 to day 4 ]
• Sum of 5 single local common cold symptom scores (sore throat, blocked nose, runny nose, cough and sneezing), mean over days 2 to 4 [ Time Frame: Day 2 to day 4 ]
• Area under the curve (AUC) over the 10-day period for the TSS [ Time Frame: Day 1 to day 10 ]
• Duration of the Cold [ Time Frame: Up to 10 days ]
• Patient Overall Assessment of Efficacy [ Time Frame: Day 1 to day 10 ]

Information By: Boehringer Ingelheim

Dates:
Date Received: September 13, 2013
Date Started: September 2013
Date Completion:
Last Updated: April 2, 2015
Last Verified: March 2015