Efficacy and safety of iota-carrageenan nasal spray versus placebo in early treatment of the common cold in adults: the ICICC trial
Author(s)
Type
Journal Article
Abstract
ota-carrageenan (I-C) is active against respiratory viruses in vitro and was effective as nasal spray in three previous
clinical trials. The current trial served to further investigate I-C in patients with early common cold symptoms.
Methods: This randomized, placebo-controlled, double-blind phase IV trial was conducted in 200 adult patients
with self-diagnosed colds of <48 h’ duration that were confirmed by baseline cold symptom scores. Patients were
to self-administer 0.12 % I-C or placebo spray (NaCl 0.5 %) four times daily for four to ten days and record symptom
information for ten days. Common respiratory viruses were quantified by RT-PCR during pretreatment and on Day 3
or 4. The primary endpoint was the mean total symptom score (TSS) of eight cold symptoms on Days 2–4 (TSS2–4).
Results: Patients in both treatment groups had similar baseline TSSs (mean TSS: 6.75 for I-C and 6.79 for placebo).
Viruses were detected in baseline samples from 53 of 98 I-C patients (54.1 %) and 54 of 97 placebo patients
(55.7 %). Mean ± SE for TSS2–4 was 5.78 ± 0.25 for I-C patients and 6.39 ± 0.25 for placebo (p = 0.0895). Exploratory
analyses after unblinding (TSS2–4 excluding a patient with aberrantly high symptom scores [TSS2–4, ex 1pt]; mean of
TSS over Days 1–4 [TSS1–4]; change in TSS1–4 relative to baseline [TSS1–4, rel]) demonstrated treatment differences in
favor of I-C (p = 0.0364, p = 0.0495 and p = 0.0421, respectively). For patients with quantifiable rhinovirus/enterovirus
at baseline, there was a trend towards greater reduction of virus load at Day 3 or 4 (p = 0.0958; I-C: 90.2 %
reduction in viral load; placebo: 72.0 %). Treatments were well tolerated with no differences in adverse event rates.
Conclusions: The primary endpoint did not demonstrate a statistically significant difference between I-C and
placebo but showed a trend towards I-C benefit. Exploratory analyses indicated significant reduction of cold
symptoms in the I-C group relative to placebo during the first four days when symptoms were most severe, and
also substantiated I-C’s activity against rhinovirus/enterovirus.
clinical trials. The current trial served to further investigate I-C in patients with early common cold symptoms.
Methods: This randomized, placebo-controlled, double-blind phase IV trial was conducted in 200 adult patients
with self-diagnosed colds of <48 h’ duration that were confirmed by baseline cold symptom scores. Patients were
to self-administer 0.12 % I-C or placebo spray (NaCl 0.5 %) four times daily for four to ten days and record symptom
information for ten days. Common respiratory viruses were quantified by RT-PCR during pretreatment and on Day 3
or 4. The primary endpoint was the mean total symptom score (TSS) of eight cold symptoms on Days 2–4 (TSS2–4).
Results: Patients in both treatment groups had similar baseline TSSs (mean TSS: 6.75 for I-C and 6.79 for placebo).
Viruses were detected in baseline samples from 53 of 98 I-C patients (54.1 %) and 54 of 97 placebo patients
(55.7 %). Mean ± SE for TSS2–4 was 5.78 ± 0.25 for I-C patients and 6.39 ± 0.25 for placebo (p = 0.0895). Exploratory
analyses after unblinding (TSS2–4 excluding a patient with aberrantly high symptom scores [TSS2–4, ex 1pt]; mean of
TSS over Days 1–4 [TSS1–4]; change in TSS1–4 relative to baseline [TSS1–4, rel]) demonstrated treatment differences in
favor of I-C (p = 0.0364, p = 0.0495 and p = 0.0421, respectively). For patients with quantifiable rhinovirus/enterovirus
at baseline, there was a trend towards greater reduction of virus load at Day 3 or 4 (p = 0.0958; I-C: 90.2 %
reduction in viral load; placebo: 72.0 %). Treatments were well tolerated with no differences in adverse event rates.
Conclusions: The primary endpoint did not demonstrate a statistically significant difference between I-C and
placebo but showed a trend towards I-C benefit. Exploratory analyses indicated significant reduction of cold
symptoms in the I-C group relative to placebo during the first four days when symptoms were most severe, and
also substantiated I-C’s activity against rhinovirus/enterovirus.
Date Issued
2015-10-05
Date Acceptance
2015-09-18
Citation
Respiratory Research, 2015, 16
ISSN
1465-993X
Publisher
BioMed Central
Journal / Book Title
Respiratory Research
Volume
16
Copyright Statement
© 2015 Eccles et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
License URL
Subjects
Science & Technology
Life Sciences & Biomedicine
Respiratory System
Iota-carrageenan
Common cold
Human rhinovirus
Clinical trial
RANDOMIZED CONTROLLED-TRIAL
CLINICAL IMPACT
DOUBLE-BLIND
SYMPTOMS
IRRIGATION
INFECTION
BACTERIA
Publication Status
Published
Article Number
121