Iota-Carrageenan Nasal Spray in Common Cold

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01944631
First received: September 13, 2013
Last updated: April 2, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Common Cold
Device: Placebo
Device: Iota-Carrageenan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4) [ Time Frame: Days 2, 3 and 4 ] [ Designated as safety issue: No ]

    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) [ Time Frame: Days 2, 3 and 4 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 200
Study Start Date: September 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Nasal spray 4 times a day over 4 to 10 days
Device: Placebo
Nasal spray saline
Experimental: Iota-Carrageenan nasal spray
Nasal spray 4 times a day over 4 to 10 days
Device: Iota-Carrageenan
Nasal spray containing 1.20 g/l Iota-Carrageenan in saline

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944631

Locations
United Kingdom
1326.1.44001 Boehringer Ingelheim Investigational Site
Cardiff, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01944631     History of Changes
Other Study ID Numbers: 1326.1
Study First Received: September 13, 2013
Results First Received: February 27, 2015
Last Updated: April 2, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 30, 2015