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Efficacy of a carrageenan nasal spray in patients with common cold: a randomized controlled trial.
Respir Res 2013; 14:124RR

Abstract

BACKGROUND

The common cold is the most widespread viral infection in humans. Iota-carrageenan has previously shown antiviral effectiveness against cold viruses in clinical trials. This study investigated the efficacy of a carrageenan-containing nasal spray on the duration of the common cold and nasal fluid viral load in adult patients.

METHODS

In a randomized, double-blind, placebo-controlled trial, 211 patients suffering from early symptoms of the common cold were treated for seven days. Application was performed three times daily with either a carrageenan-supplemented nasal spray or saline solution as placebo with an overall observation period of 21 days. The primary endpoint was the duration of disease defined as the time until the last day with symptoms followed by all other days in the study period without symptoms. During the study, but prior unblinding, the definition of disease duration was adapted from the original protocol that defines disease duration as the time period of symptoms followed by 48 hours without symptoms.

RESULTS

In patients showing a laboratory-confirmed cold virus infection and adherence to the protocol, alleviation of symptoms was 2.1 days faster in the carrageenan group in comparison to placebo (p = 0.037). The primary endpoint that had been prespecified but was changed before unblinding was not met. Viral titers in nasal fluids showed a significantly greater decrease in carrageenan patients in the intention-to-treat population (p = 0.024) and in the per protocol population (p = 0.018) between days 1 and 3/4.

CONCLUSIONS

In adults with common cold virus infections, direct local administration of carrageenan with nasal sprays reduced the duration of cold symptoms. A significant reduction of viral load in the nasal wash fluids of patients confirmed similar findings from earlier trials in children and adults.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN80148028.

Authors+Show Affiliations

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableDepartment of Otorhinolaryngology, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria. christian.a.mueller@meduniwien.ac.at.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24219370

Citation

Ludwig, Martin, et al. "Efficacy of a Carrageenan Nasal Spray in Patients With Common Cold: a Randomized Controlled Trial." Respiratory Research, vol. 14, 2013, p. 124.
Ludwig M, Enzenhofer E, Schneider S, et al. Efficacy of a carrageenan nasal spray in patients with common cold: a randomized controlled trial. Respir Res. 2013;14:124.
Ludwig, M., Enzenhofer, E., Schneider, S., Rauch, M., Bodenteich, A., Neumann, K., ... Mueller, C. A. (2013). Efficacy of a carrageenan nasal spray in patients with common cold: a randomized controlled trial. Respiratory Research, 14, p. 124. doi:10.1186/1465-9921-14-124.
Ludwig M, et al. Efficacy of a Carrageenan Nasal Spray in Patients With Common Cold: a Randomized Controlled Trial. Respir Res. 2013 Nov 13;14:124. PubMed PMID: 24219370.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of a carrageenan nasal spray in patients with common cold: a randomized controlled trial. AU - Ludwig,Martin, AU - Enzenhofer,Elisabeth, AU - Schneider,Sven, AU - Rauch,Margit, AU - Bodenteich,Angelika, AU - Neumann,Kurt, AU - Prieschl-Grassauer,Eva, AU - Grassauer,Andreas, AU - Lion,Thomas, AU - Mueller,Christian A, Y1 - 2013/11/13/ PY - 2013/08/01/received PY - 2013/11/10/accepted PY - 2013/11/14/entrez PY - 2013/11/14/pubmed PY - 2014/7/9/medline SP - 124 EP - 124 JF - Respiratory research JO - Respir. Res. VL - 14 N2 - BACKGROUND: The common cold is the most widespread viral infection in humans. Iota-carrageenan has previously shown antiviral effectiveness against cold viruses in clinical trials. This study investigated the efficacy of a carrageenan-containing nasal spray on the duration of the common cold and nasal fluid viral load in adult patients. METHODS: In a randomized, double-blind, placebo-controlled trial, 211 patients suffering from early symptoms of the common cold were treated for seven days. Application was performed three times daily with either a carrageenan-supplemented nasal spray or saline solution as placebo with an overall observation period of 21 days. The primary endpoint was the duration of disease defined as the time until the last day with symptoms followed by all other days in the study period without symptoms. During the study, but prior unblinding, the definition of disease duration was adapted from the original protocol that defines disease duration as the time period of symptoms followed by 48 hours without symptoms. RESULTS: In patients showing a laboratory-confirmed cold virus infection and adherence to the protocol, alleviation of symptoms was 2.1 days faster in the carrageenan group in comparison to placebo (p = 0.037). The primary endpoint that had been prespecified but was changed before unblinding was not met. Viral titers in nasal fluids showed a significantly greater decrease in carrageenan patients in the intention-to-treat population (p = 0.024) and in the per protocol population (p = 0.018) between days 1 and 3/4. CONCLUSIONS: In adults with common cold virus infections, direct local administration of carrageenan with nasal sprays reduced the duration of cold symptoms. A significant reduction of viral load in the nasal wash fluids of patients confirmed similar findings from earlier trials in children and adults. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80148028. SN - 1465-993X UR - https://www.unboundmedicine.com/medline/citation/24219370/Efficacy_of_a_carrageenan_nasal_spray_in_patients_with_common_cold:_a_randomized_controlled_trial_ L2 - https://respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-14-124 DB - PRIME DP - Unbound Medicine ER -