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The once-a-day Pulmicort Turbuhaler, approved by the U.S. Food and Drug Administration (FDA) in October, has created quite a stir among asthma patients and physicians.
With some qualification, experts agree the Pulmicort Turbuhaler by Astra Pharmaceuticals in Westborough, MA, will be effective in encouraging compliance among mild to moderate asthmatics.
Linda Ford, MD, president of the American Lung Association who practices at the Asthma and Allergy Center in Omaha, NE, says the product is not effective for severe asthmatics.
"Where those with milder asthma can get by on once-a-day inhaled steroids, whether it is Pulmicort or any other product, severe asthmatics need a heftier dose," Ford says. "We know that inhaled steroids work best when divided into several doses during the day."
On the other hand, Ford thinks once-a-day dosage will improve compliance among appropriate patients who use it.
She says patients with mild persistent asthma who have peak flow plans and follow them can use Pulmicort or any other inhaled steroids on a once-a-day basis, although Astra is the only company that has done a study on that type of usage.
"It’s nice to know, but it’s probably not brand-specific, but class-specific," she adds. "We’ve been doing it that way for a long time with mild asthma."
However, Pulmicort may have a very specific affect on "real world" compliance, says James L. Sublett, MD, FAAAI, national medical director of Vivra Asthma and Allergy Research Institute in Louisville, KY, a practicing allergist who participated in the Pulmicort clinical trials. "Especially for that group of mild to moderate persistent asthmatics, I think the biggest advantage of single daily dosing will be improving compliance," he says. "I think the patients’ perception of single daily dosing is better and the likelihood of them following a treatment plan will be enhanced."
Pulmicort is not much different from several other inhaled steroids not technically approved by the FDA for that purpose which could be used with the same results in mild to moderate persistent asthmatics, Sublett says, "It’s just that [Astra] is the first one to get FDA approval."
Sublett sees Pulmicort and Flovent (Glaxo-Wellcome’s new and slightly more potent inhaled steroid) as "the next generation of asthma treatment drugs."
And while clinical results show a slightly better outcome for patients with twice daily dosing, Sublett says, "When you come down to real world situations, a lot of patients miss dosages anyway, so in the real world quality of life studies, a lot of times single daily dosage is just as effective."
Ford agrees. "People who have mild persistent asthma don’t have a lot of symptoms, and they don’t like taking medications two times or three times a day. So they are probably [taking one dose a day] anyway."
To Ford there is another key benefit to this new generation of drugs: Physicians have learned that single daily dosage steroids can provide day-to-day disease management for mild to moderate asthmatics. "If [the FDA approval of Pulmicort] does nothing more than teach physicians that, yes, you can alter, you can step up and step down therapy with inhaled steroids, it would be helpful," she explains.
Ford says many physicians may not realize that with a competent management plan, severe or moderate persistent asthmatics can be converted to a mild persistent form of the disease, and over time, benefit from once-a-day dosage.
Ross Rocklin, MD, Astra’s senior director of clinical research, says Pulmicort is different from other inhaled steroids because most inhaled steroids are administered two to four times a day. "We were originally approved for twice-a-day dosing, and this approval is to have once-a-day dosing. This means a patient receiving a total dose of 400 mg a day in two, three, or four doses can be transferred to two inhalations of Pulmicort either in the morning or evening and you can achieve or maintain the same clinical control."
"The advantage for the patient is for compliance," he says. "They can take it once a day, but get their full dose with Pulmicort."
Rocklin says the Turbuhaler delivery system is unique, as the first dry powder inhaler to win FDA approval two years ago: "The advantage is that it delivers approximately twice as much drug to the lung" as other inhalers.
As a delivery system, Sublett and Ford agree, Astra’s Turbuhaler gets good reviews from patients and physicians alike.
The non-aerosol, non-fluorocarbon inhaler works on a different principle than other types, requiring the patient to breathe in slowly and hold for a count of ten to release the drug.
"For some people who have difficulty taking inhalers and can’t get that eye-hand coordination well, this works quite well," Ford says. "It’s like a sucking action. The inspiratory pressure has to be quite high."
Sublett says the nonmetered dose inhalers are probably "the wave of the future."Patients like the Turbuhaler, he says, because "you can’t feel the drug going in at all, which in some ways is a plus because you don’t have to worry about the taste factor, but it is different from what some patients are used to."
He says new drugs such as Pulmicort provide the quality of life for patients and positive outcomes in terms of emergency room admissions. "It’s another tool we can use to improve our care."
Sublett notes technology is changing rapidly in terms of asthma management. Several new drugs and delivery systems are "on the horizon," including a nebulizer solution for Pulmicort nearing FDA approval that provided "very dramatic" results in asthmatics as young as one year old.
[For more information, contact the American Lung Association, (800) LUNGUSA, or Ross Rocklin, MD, Astra Pharmaceuticals, (508) 366-1100.]