14 DAY TRIAL // Three Canadian research teams are launching a new and rare trial that aims to test whether a new Canadian medicine approved by Health Canada for adults, could also help parents get rid of their kids' colds.
A positive safety trial was already published in Pediatrics – the official journal of the American Academy of Pediatrics, so it's now time for a landmark trial including 500 children.
At this time in Canada there is a controversy involving pediatric cold and flu medicines, as most of the hundreds of OTC cold treatments for children that are available in pharmacies did not pass any clinical safety, efficacy or dosing trials.
Back in 2007, an FDA report concluded that from 1954 to 2004, there were only 11 published trials of over-the-counter (OTC) cough and cold products for kids, none of which was proven efficient.
For the trial announced today, 500 children aged between 3 and 11 years, will be recruited and the campaign started already.
The scientists estimate that nearly 60% of the participants will develop an infection and then be allowed to enter the clinical trial.
All kids will be encouraged to get their flu vaccine, and each one will randomly be chosen to take a special children's formulation of COLD-FX or a placebo for three days (researchers will monitor the children for 14 days).
Researchers in Edmonton, Halifax and Saint John, New Brunswick will use a patented extract of North American ginseng called COLD FX which is currently the first selling adult cold and flu medicine in Canada.
This product is backed by 11 clinical trials, most of them conducted at 8 universities in both Canada and the US.
Dr. Jacqueline Shan, who was part of the team that discovered COLD-FX, says: “we hope this multi-center trial will be viewed as timely and beneficial research in an area where there are few options for parents and a clear need for safe and effective clinically proven products to treat cold and flu in children.”
This is one of the very few OTC trials ever conducted for cold and flu medicine for children and it is very important as kids get between 6 and 10 colds a year and miss millions of school days.
Also, there are studies that show that 10% of children take cough and cold medicines each week in America, and the Center for Disease Control and Prevention (CDC) says that every year over 7,000 children under 12 years of age are treated in US emergency rooms for adverse reactions to pediatric cough and cold medicines.