![]() Written informed consent was obtained from each participant before enrolment into the study. The Ethics Committee of the participating site approved the protocol and all amendments. The study was performed in compliance with the ICH E6 Note for Guidance on Good Clinical Practices (CPMP/ ICH/ 135/ 95/ 5) and the principles of the Declaration of Helsinki. Specifically, during the treatment period (days 1–7), use of any other nasal spray, nonsteroidal anti-inflammatory drugs, antihistamines, decongestants, corticosteroids, antivirals, antitussives, herbal combinations for common colds and supplements containing ≥10 mg zinc or ≥100 mg vitamin C were prohibited. Main exclusion criteria were known hypersensitivity or allergy to any component of the test product, concomitant disease or infection that could interfere with participation in the study, other reasons for nasal obstruction and other past or present conditions and treatments that could influence symptom scores. TSS was calculated by investigators as the sum of individual scores. Patients scored eight main symptoms (headache, muscle ache, chilliness, sore throat, blocked nose, runny nose, coughing and sneezing) using a four point scale as follows: 0 (symptom absent) and 1, 2 and 3 representing mild, moderate and severe intensity, respectively. The intensity of common cold symptoms was assessed according to a published scoring system. ![]() Eligible patients were adults (18 years and older) with early symptoms of the common cold (onset less than 48 hours before inclusion) of mild to moderate intensity (Total Symptoms Score, of 2 to 9). This study was designed to investigate the efficacy of a carrageenan-containing nasal spray on the duration of the common cold and the viral load in nasal fluid in adult patients.Īll patients were recruited at the Department of Otorhinolaryngology of the Vienna General Hospital, Austria between January, 2010 and April, 2011. In addition to preclinical studies, symptomatic benefit and antiviral efficacy of a nasal spray containing carrageenan has been shown in two randomized clinical trials in adult and pediatric patients with the common cold. ![]() Therefore, pharmacological, immunological or metabolic activities of carrageenan are not to be expected. Tests in vitro have shown that carrageenan does not penetrate the mucosa. Studies in vitro and in vivo have shown the effectiveness of carrageenan against several viruses such as hRV, influenza A and RSV. Thus, carrageenan interferes with the virus life cycle at a very early stage due to a physical mechanism of action. Laboratory data show that the carrageenan-polymer binds directly to the virus but not to cells trapping the particle and preventing cell attachment. Recently it was shown that iota-carrageenan, a sulphated polysaccharide found in some species of red seaweed, is a potent antiviral agent against respiratory viruses in cell culture and animal models. ![]() However, these polysaccharides have been tested to prevent sexually transmitted viral infections as a component of spermicides. For the treatment of sexually transmitted diseases, research has focused on topical microbicide development although not enough evidence has accumulated to recommend these agents at present. Due to the high molecular weight of polymers, parenteral administration is not feasible. The concept of using sulphated polysaccharides as antiviral agents was introduced more than 25 years ago. While these measures reduce symptoms, therapeutic interventions to date have not been proven to be effective in reducing viral load or the duration or severity of common colds. Presently, therapy for the common cold mainly includes general care and treatment of symptoms. Numerous attempts to find effective prophylactic or therapeutic treatments including pharmaceutical and herbal products, vitamins, zinc and others have provided controversial results and are not considered effective when systematically reviewed. The number of etiological agents and antigenic variability has limited the possibility of creating an effective vaccine against the common cold. In the majority of cases, common colds are caused by respiratory viruses such as rhinovirus, coronavirus, parainfluenza, influenza, respiratory syncytial virus, adenovirus, enterovirus, or metapneumovirus. With a total economic impact of approximately $40 billion, ARTI is among the ten most expensive illnesses in society. In the USA alone, non-influenza colds annually account for more than 20 million doctor visits and 40 million lost school and work days. ![]() Acute viral respiratory tract infection (ARTI), also known as the common cold, is the most prevalent disease in humans. ![]()
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