New multi-centre trial to treat cold and flu in children

Oct 22 2010

Parents want it -- a proven cold treatment for children

Three Canadian research teams are trying to determine if a novel Canadian medicine approved by Health Canada for adults can help parents deal with the hacking coughs and runny noses their children suffer. Five hundred children will be recruited for a landmark trial, which follows a positive safety trial that was published in Pediatrics - the official journal of the American Academy of Pediatrics.

The trial comes at a time of considerable controversy involving pediatric cold and flu medicines. Critics argue, and the FDA agrees, that most of the hundreds of OTC cold treatments for children currently on pharmacy shelves have not gone through clinical safety, efficacy and dosing trials. In 2007, an FDA summary report concluded that for the 50 year period ending in 2004, there were only 11 published trials of OTC cough and cold products for children and none demonstrated efficacy. The federal agency is attempting to change that by offering the industry extended patents when they conduct pediatric research. A major gap remains. Today's announcement of a multi-centre randomized, double-blind placebo-controlled trial is one of the very few trials ever conducted for any cold and flu over the counter medicine for children.

Children get an estimated 6 to 10 colds a year and as a result miss millions of school days. Studies show that 10% of children are given cough and cold medicines each week in America. The Centre for Disease Control and Prevention (CDC) says that every year more than 7,000 children under 12 years of age are treated in U.S. emergency rooms for adverse reactions to pediatric cough and cold medicines.

Researchers in Edmonton, Halifax and Saint John, New Brunswick will focus on a patented extract of North American ginseng called COLD FX- which is currently the # 1 selling adult cold and flu medicine in Canada. It's backed by eleven clinical trials, most of them conducted at 8 universities in both Canada and the U.S. The FDA has cleared its sale in the U.S. for adults under new dietary ingredient (NDI) legislation.

Recruitment of 500 children, three to 11 years of age, began today. Researchers estimate that approximately 60% of the children in the study will develop an infection and then be eligible to enter the clinical trial. Children will be encouraged to get their annual flu shot. Each child will be randomized to take either a special children's formulation of COLD-FX or a placebo for three days. They will be closely monitored for 14 days.

Dr. Jacqueline Shan, who along with a team of 24 other scientists discovered COLD-FX, says, "We hope this multi-centre 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."