Afexa Life Sciences Inc, the maker of COLD-FX, has launched a paediatric clinical trial to explore the potential application of COLD-FX in children.
The Clinical Study: The clinical trial, the second in a series, is a multi-centre, randomized, double-blind, placebo-controlled trial designed to assess the potential benefit of COLD-FX in reducing cold and flu symptoms in children. A total of 500 children, aged three to 11, will be recruited from three locations - Halifax, Saint John, and Edmonton. Investigators estimate that approximately 60 per cent of these children, or 300, will develop an infection and then be eligible to enter the clinical trial. Children will be encouraged to get their annual flu shot. Clinical trial participants will be randomized to take either a special formulation of COLD-FX for children or a placebo for three days, and will be closely monitored for 14 days.
The Clinical Investigators – Halifax: Dr Shelly McNeil (lead investigator), associate professor of Medicine, Dalhousie University, Infectious Disease Specialist, Capital District Health Authority, Canadian Center for Vaccinology, IWK Health Centre; Edmonton: Dr Gerry Predy, senior medical officer of Health, Alberta Health Services; and Saint John: Dr Marianne McKenna, general paediatrician, Saint John Regional Hospital, New Brunswick
Both the United States Food and Drug Administration (FDA) and Health Canada have issued advisory statements related to safety and efficacy on many pediatric OTC drugs for colds and flu, with Health Canada prohibiting the marketing of these products to children under six years of age.
In addition to the FDA and Health Canada advisories, in May of 2010 over 40 brand-name over-the-counter drugs for children were voluntarily recalled either because they did not meet quality standards or were thought to have a higher concentration of active ingredient than specified.
Dr Predy, a co-investigator in the study, says, "Ensuring the safety and efficacy of medication is vital, and research into the safety and efficacy of pediatric over-the-counter cold and flu drugs is likewise important to the health of our children. This study attends to the unique needs of children, and the outcomes will benefit further development of pediatric-specialized products."
Another member of the research team, Dr Scott Halperin, director, of the Canadian Center for Vaccinology, says, "The Center is pleased to participate in this study, given our past research in the COLD-FX for Seniors Study. Although there is significant activity in the area of pediatric vaccines, to my knowledge, the COLD-FX study is the only on-going multi-centre randomized controlled study of a pediatric drug for treatment of colds and flu."
Dr Jacqueline Shan, Afexa's co-founder and chief scientific officer, says, "Our emphasis on standardization and consistency through our ChemBioPrint process ensures our products meet quality standards. Safety and efficacy are paramount, particularly when caring for our children. Few paediatric products on the market today have gone through clinical trials; dosage is often based simply on a lower dosage of the adult product. At Afexa we recognize that it is important to ensure products are designed and tested to meet the unique needs of children. We are taking a leadership position in the advancement of paediatric health by conducting this cold and flu clinical research. Our commitment to science is addressing a significant therapeutic need in children."
The current study is a follow-up to a positive randomized, placebo-controlled trial completed at the University of Alberta and published in 2008 in Paediatrics – the official journal of the American Academy of Paediatrics. That published pilot study demonstrated the safety of COLD-FX in a paediatric population and provided early signals of efficacy, which were used to design the current study.
The current study was set to begin during last year's cold and flu season, but was re-scheduled due to the H1N1 flu pandemic. The study has clearance from Health Canada and approval by all required Health Research Ethics Boards.
Afexa Life Sciences Inc, founded in 1992, strives to deliver the most trusted health brand on the planet through pioneering evidence-based natural medicines that empower people to achieve their health potential.