Randomized, Placebo-Controlled Double-Blind Pilot Study of Pioglitazone Hydrochloride in Allegic Asthma
EPISODE #3
Uploaded: November 4, 2008
Running Time: 4:58
SCHMALFELDT: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO.
According to the National Heart, Lung and Blood Institute at the NIH, 22 million Americans suffer from asthma. About ten percent of asthma sufferers get no relief from standard treatments that work on others. But when two Japanese patients with both asthma and type 2 diabetes began taking a drug to treat their diabetes and noticed their asthma symptoms improved as well - that caused some raised eyebrows in the world of clinical research.
LEVINE: So, we thought, OK, it's anecdotal, it's only two patients, but that's some evidence that it might potentially be effective.
SCHMALFELDT: That was Dr. Stewart Levine, principal investigator with NHLBI's Pulmonary and Vascular Critical Care Medical Branch, explaining why researchers at the NIH Clinical Center are launching a pilot study to see if there truly is a connection between the diabetes drug pioglitazone hydrochloride - known by the brand name of Actos - and improvement in asthma symptoms. Dr. Levine indicated that experimental data also exists to support this concept and he explained the study protocol.
LEVINE: So we've recently launched and we're quite excited about our study. It's a randomized, double-blind, placebo-controlled design. It's aimed at patients who have severe asthma and are poorly controlled despite treatment with high doses of inhaled steroids. And what I mean by that is that these poorly-controlled patients need to use their rescue albuterol inhaler more than twice a week or have symptoms that wake them up from asthma more than one time per week. Now, the protocol will have three phases. The first phase will be a "run in" phase to ensure that patients have stable asthma. The second phase will be a "treatment phase" - and here, they'll receive either the placebo, which is a sugar pill essentially, or the pioglitazone, which is the study medication, and neither the patients nor we the investigators will know what the patients are receiving. They'll receive the treatment for ten weeks. And then after ten weeks they'll enter the third phase of the study, which is a "wash out" period. In between the second and third phase of the study, we'll determine the primary end point of the protocol, which will be to see whether the patients who received the pioglitazone have an improvement in their post-bronchodilator FEV1 following treatment. And this will be a measure of how well patients can breathe, and we'll see whether they're breathing has improved with the pioglitazone treatment as compared to those who received the placebo.
SCHMALFELDT: Dr. Levine said if the study yields promising results, the next step would be to open it up in a few years to patients with severe asthma at several different locations. He said if pioglitazone or some other medication is shown to be effective for treatment of patients with severe asthma, it would present a wonderful option to those patients.
LEVINE: There are really only two treatment options for patients with severe, persistent asthma and are still symptomatic despite treatment with the recommended therapy, which is high doses of steroids and long-acting beta agonists. One option is to place them on oral corticosteroids, such as prednisone. Now, this can be very effective, but it has significant side effects, such that it represents real medical problems for patients who need this therapy long term. And also, patients just don't like being on oral corticosteroids for long periods of time. The only other option that's recommended at this point is anti-IgE treatment, which goes by the trade name Xolair, and this can be very effective in a subset of patients that have allergic asthma. However, the limitations regarding this approach are that anti-IgE therapy requires parenteral administration and this means that patients need to see their health care provider either twice monthly or monthly to receive an injection, it's expensive, and there's a small incidence of significant side effects. So we think there's an unmet need for development of new treatment approaches for patients who have persistently symptomatic severe asthma. We're hoping we can fill this void by the introduction of new treatment approaches, and pioglitazone is one that we are considering.
SCHMALFELDT: If you would like more information about clinical trials, log on to http://clinicalcenter.nih.gov, or e-mail prpl@mail.cc.nih.gov. You may also call, toll free, 1-866-999-5553. From America's Clinical Research Hospital, this has been Episode One of CLINICAL CENTER RADIO. In Bethesda, Maryland, I'm Bill Schmalfeldt at the National Institutes of Health, an agency of the United States Department of Health and Human Services.
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