Lessons learned from a double-blind randomised placebo-controlled study with a iota-carrageenan nasal spray as medical device in children with acute symptoms of common cold

Abstract

Background: Common cold is caused by a variety of respiratory viruses. The prevalence in children is high, and it potentially contributes to significant morbidity. Iota-carragenan, a polymer derived from red seaweed, has reduced viral load in nasal secretions and alleviated symptoms in adults with common cold.

Methods: We have assessed the antiviral and therapeutic activity of a nasal spray containing iota-carrageenan in children with acute symptoms of common cold. A cohort of 153 children between 1-18 years (mean age 5 years), displaying acute symptoms of common cold were randomly assigned to treatment with a nasal spray containing iota-carrageenan (0.12%) as verum or 0.9% sodium chloride solution as placebo for seven days. Symptoms of common cold were recorded and the viral load of respiratory viruses in nasal secretions was determined at two consecutive visits.

Results: The results of the present study showed no significant difference between the iota carrageenan and the placebo group on the mean of TSS between study days 2-7. Secondary endpoints, such as reduced time to clearance of disease (7.6 vs 9.4 days; p = 0.038), reduction of viral load (p = 0.026), and lower incidence of secondary infections with other respiratory viruses (p = 0.046) indicated beneficial effects of iota-carrageenan in this population. The treatment was safe and well tolerated, with less side effects observed in the verum group compared to placebo.

Conclusion: In this study iota-carrageenan did not alleviate symptoms in children with acute symptoms of common cold, but significantly reduced viral load in nasal secretions that may have important implications for future studies.

Trial registration: ISRCTN52519535, http://www.controlled-trials.com/ISRCTN52519535/

Figure 1

Virus Distribution. The distribution of respiratory viruses is shown in percent of total positive specimens. Parainfluenzavirus includes subtypes 1–3; Coronavirus includes subtypes 229E and OC43.

Figure 2

Symptom scores in the ITT and PP cohort.

Figure 3

Enrollment and randomization scheme.

Figure 4

Alleviation of symptoms in patients with early symptoms of common cold treated either with iota-carrageenan nasal spray or placebo nasal spray. Alleviation was defined as persistent disappearance of symptoms during the observation period. Patients with recurrent disease were rated as symptomatic until complete resolution of symptoms. (A) Cumulative percentage of patients from the ITT population with complete persistent alleviation of symptoms (p < 0.038). (B) Rhinovirus-positive patients (n.s. p = 0.06). (C) Coronavirus-positive patients (p < 0.002). P-values were determined by the Log-rank (Mantel-Cox) test.

Figure 5

Reduction of viral load between visits 1 and 2. The log₁₀ of the virus copies was determined by quantitative PCR analysis, and the difference in viral load between visits was calculated for the verum and the placebo group. The log₁₀ difference in total virus copy number (±SEM) between visits 1 and 2 is shown (p < 0.026).