12/29/2023 0 Comments Iota carrageenan nasal spray amazon![]() ![]() In all 3 trials, there were indications of efficacy, including significantly reduced cold symptoms positive effects on symptoms in patients in whom less co-medication or no co-medication was used significantly reduced viral loads and faster reduction of common cold symptoms. Between 20, three randomized clinical trials (two in adults and one in children) were conducted comparing I-C nasal spray with saline solution (placebo). This product has recently been licensed to Boehringer Ingelheim, the sponsor of the current study. Therefore, a nasal spray containing 0.5 % saline and 0.12 % iota-carrageenan (I-C nasal spray) has been developed and registered as a medical device. Because the primary site of infection and replication of most cold-causing viruses is the nasal mucosa, it was speculated that early and targeted treatment of the nasal mucosa with I-C may block viral entry at the level of the respiratory mucosa, and interfere locally with the propagation of viral replication. Carrageenan is generally recognized as safe (GRAS) for use in food and topical applications. In vitro tests have established that I-C does not penetrate freshly excised bovine nasal mucosa, and therefore is not absorbed systemically (data on file, Marinomed Biotechnology GmbH). In vitro and in vivo studies have demonstrated the effectiveness of I-C against several viruses such as HRV and influenza A. The I-C polymer seems to bind directly to viruses, preventing viral attachment to host cells. Iota-carrageenan (I-C)-a sulfated polysaccharide found in some species of red seaweed ( Chondrus crispus) - has demonstrated antiviral activity against respiratory viruses in cell culture and in animal models. With the exception of influenza and RSV, there are no vaccinations or anti-viral medicinal products available for treatment of infection with the viruses that cause the common cold. It has been estimated that the total economic impact of non–influenza-related viral upper respiratory tract infections approaches $40 billion annually, and such infections can result in serious and even life-threatening sequelae in patients with underlying illnesses such as asthma, COPD or immune compromise. Common colds are frequent illnesses in both children and adults on average, adults report 2.5 episodes per year. In adults, rhinoviruses cause approximately 50 % of common colds and up to 90 % of colds during the autumn epidemic season. Rhinoviruses are the most common cause of respiratory tract infections in individuals of all ages. 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 %). 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. 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. ![]()
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