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The common cold is caused by a variety of respiratory viruses, such as human rhinoviruses (HRV), coronaviruses, human enteroviruses (HEV), respiratory syncytial virus (RSV), parainfluenza viruses, or influenza viruses. 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. The primary endpoint did not demonstrate a statistically significant difference between I-C and placebo but showed a trend towards I-C benefit. Treatments were well tolerated with no differences in adverse event rates. 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 %). Exploratory analyses after unblinding (TSS 2–4 excluding a patient with aberrantly high symptom scores mean of TSS over Days 1–4 change in TSS 1–4 relative to baseline ) demonstrated treatment differences in favor of I-C ( p = 0.0364, p = 0.0495 and p = 0.0421, respectively). Viruses were detected in baseline samples from 53 of 98 I-C patients (54.1 %) and 54 of 97 placebo patients (55.7 %).
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Patients in both treatment groups had similar baseline TSSs (mean TSS: 6.75 for I-C and 6.79 for placebo). The primary endpoint was the mean total symptom score (TSS) of eight cold symptoms on Days 2–4 (TSS 2–4). Common respiratory viruses were quantified by RT-PCR during pretreatment and on Day 3 or 4. 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.
Iota carrageenan trial#
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. The current trial served to further investigate I-C in patients with early common cold symptoms. Iota-carrageenan (I-C) is active against respiratory viruses in vitro and was effective as nasal spray in three previous clinical trials.