Iota-Carrageenan Nasal Spray in Common Cold

NCT01944631 | Completed Phase 4 Results

• 1 other identifier: 1326.1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• 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).

  Days 2, 3 and 4

Secondary Outcomes (5)

• Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)

  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)

  Days 2, 3 and 4

• 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

• Duration of the Cold

  Baseline up to 10 days

• Patient Overall Assessment of Efficacy

  Day 10

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Nasal spray 4 times a day over 4 to 10 days

Device: Placebo

Iota-Carrageenan nasal spray

EXPERIMENTAL

Nasal spray 4 times a day over 4 to 10 days

Device: Iota-Carrageenan

Interventions

Placebo DEVICE

Nasal spray saline

Placebo

Iota-Carrageenan DEVICE

Nasal spray containing 1.20 g/l Iota-Carrageenan in saline

Iota-Carrageenan nasal spray

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Known hypersensitivity or are allergic to any component of the test device
• 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
• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1326.1.44001 Boehringer Ingelheim Investigational Site

Cardiff, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26438038 DERIVED

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 17, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 3, 2015
• Results First Posted: April 3, 2015

Record last verified: 2015-03

Locations

GB (1)