Efficacy of a carrageenan nasal spray in patients with common cold: a randomized controlled trial.
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.


BACKGROUND
Current Controlled Trials ISRCTN80148028.
Martin
M
Ludwig
Elisabeth
E
Enzenhofer
Sven
S
Schneider
Margit
M
Rauch
Angelika
A
Bodenteich
Kurt
K
Neumann
Eva
E
Prieschl-Grassauer
Andreas
A
Grassauer
Thomas
T
Lion
Department of Otorhinolaryngology, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria. christian.a.mueller@meduniwien.ac.at.
Christian A
CA
Mueller
D000281:Administration, Intranasal; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D002351:Carrageenan / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D003139:Common Cold / Q000188:drug therapy* / Q000821:virology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017817:Nasal Lavage Fluid / Q000821:virology; D059085:Nasal Sprays; D012229:Rhinovirus / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
D000998:Antiviral Agents; D059085:Nasal Sprays; D002351:Carrageenan