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Finding the Right Tools
New Emergency Department Study Shows Promising Treatment in Adults Doesn’t Work for Kids

In a Merck-funded study just published in Annals of Allergy, Asthma and Immunology, CHORI clinical scientist and pediatric emergency medicine physician Claudia R. Morris, MD, and her colleagues demonstrated that intravenous montelukast (Singulair) had no benefit as a rescue drug in children aged 6 to 14 years seen in the emergency department (ED) for acute asthma attack. Although the results of the pediatric trial were negative, they provide valuable insight into the ability to extrapolate drug study results from adults to children.

“Previous studies of montelukast in the acute setting in adults significantly improved asthma outcomes, so it made perfect sense to try it in kids,” says Dr. Morris, who was the principle investigator for the Oakland site and lead author on the publication.

“It’s incredibly important that drug companies like Merck, the drug manufacturer, take the initiative to perform these trials in children. All too often it is assumed that because a treatment works in adults, it will work in children.”

Asthma, a chronic condition in which inflammation and the constriction of bronchial airways cause breathing difficulties, is a significant problem in the United States, and in particular in Oakland. Updated figures in the Guidelines for the Diagnosis and Management of Asthma, established in 2007 by the National Heart, Lung, and Blood Institute/National Asthma Education Prevention Program estimate that over 22 million people in the United States have asthma including more than 6.5 million children.

“It’s not surprising with those statistics that asthma is the number one reason children seek care in our ED,” says Dr. Morris. “We see over 5 thousand kids a year for asthma in just the ED alone, while in the outpatient clinic, we see over 6 thousand. Children’s Oakland ranks at the very top of pediatric hospitals in the US of seeing the most number of kids with asthma.”

As a result, Children’s Hospital & Research Center Oakland is doing all it can to find better ways of treating kids with asthma, including participating in studies like this one, sponsored by Merck.
“At least 30 percent of kids seen in EDs for asthma across the country end up getting hospitalized, which means there just aren’t enough tools in our treatment toolbox to get these kids in good enough shape to send them home.”
Like others who participated in the international, 36-site, randomized placebo-controlled montelukast study, Dr. Morris was hopeful that montelukast could expand the tools at clinicians’ disposal. The drug is already approved as a standard controller medication for asthma in both adults and children but had not been considered a rescue medicine in children for use during an acute asthma attack.

“It was very disappointing, in part because it’s a pretty benign intervention. At the same time, the fact that we didn’t get similar results in this study as in the adult studies reinforces the fact that children are not little adults,” Dr. Morris says.

“When kids are sick and they can’t breathe, they’re very distressed. It can be hard to get them to do the same breathing tests that adults are able to do without a problem.”
In addition, practitioners also have different management styles for dealing with children. They don’t always make clinical decisions based on clinical presentation alone. Instead, doctors in the ED have to make decisions based on additional factors, like the ability of the family to manage the situation, who takes care of the child, and whether they have a car or a phone if the child gets sent home and situation gets worse again. Hospitalization may depend on a whole host of these issues, in addition to the child’s emotional status, not just the clinical presentation of the asthma itself.

“Issues like these that make doing studies in children so hard to tease out when evaluating outcome measures,” says Dr. Morris.

Whether or not the differences in outcomes between adults and children were due to the challenges with children's studies or with a failure of the drug itself , montelukast, while it remains a good controller medication, now is officially shelved as an acute treatment option in children, and clinicians like Dr. Morris will have to continue to research other, newer treatment options instead.

Fortunately, studies to help find such novel treatments are already under development right here through AsthmaNet, a collaborative venture between Children’s Hospital & Research Center Oakland’s pediatric asthma center and the University of California, San Francisco’s asthma center.

In the mean time, the Merck study, though having a negative finding, provided a unique opportunity for Children’s to shine.

“We actually became the top enrolling site in the United States, which is pretty good for an ED that had never done an industry-funded project like this before,” says Dr. Morris.

“It positions us well for participation in future studies like this one, and I attribute much of our success to the outstanding staff of nurses and doctors in the ED, the Pediatric Clinical Research Center, and to the diligent efforts of my study coordinator, Michael Ansari, who continues to work with me on other funded projects since the completion of the asthma trial.”

Hopefully such projects will continue to help clinician’s like Dr. Morris to find not just more tools, but the right tools, to help children with asthma in Oakland, and everywhere, lead happier and healthier lives.
“We actually became the top enrolling site in the United States, which is pretty good for an ED that had never done an industry-funded project like this before.”

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Tuesday, May 17, 2011 8:19 AM

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