Medical Foods For Asthma

An Interview With Julianne Lindemann PhD

Can Food Improve My Asthma
Can Food Improve My Asthma.

Increasingly medical foods are coming to the forefront for the treatment of medical conditions. I recently interviewed Julianne Lindemann PhD., Senior Scientific Advisor at PanTheryx about Lunglaid and how it might impact asthma. Dr. Lindemann has more than 25 years of experience and worked as part of the team that obtained GRAS or Generally Recognized As Safe status for Lunglaid.

What Are Medical Foods?

A medical food, as defined in the Orphan Drug Act by the U.S. Food and Drug Administration, is basically a food designed to be administered under the supervision of a physician to treat an underlying condition.

It is not just “eating healthy” but targets some specific component of a disease.

In asthma, one example is Lunglaid, which targets leukotriene levels in patients with poor asthma control.

How Might a Physician or Patient Recognize a Good Patient For Lunglaid?

Since leukotrienes are a direct cause of asthma symptoms and Lunglaid both reduces production of leukotrienes and reduces asthma symptoms, potentially any patient with mild persistent or moderate persistent asthma that is not well-controlled could benefit from the addition of Lunglaid to their treatment regimen.

How Should a Patient Bring Up Lunglaid With Their Doctor?

Medical foods are not common. Most patients and many doctors are not familiar with them for the treatment of asthma or other diseases.

Dr. Lindemann suggested all asthma patients should have a written asthma action plan, and reach an agreement with their doctor about treatment goals and use of medications.

Patients interested in Lunglaid should take their action plan to their next doctor appointment and ask whether it would make sense to adjust the treatment regimen to include the daily use medical food.

Does Lunglaid Require An Asthmatic See a Specialist?

Dr. Lindemann said there is no reason for such a limitation.

General Practitioners, Family Physicians and other health care providers that treat patients with asthma can prescribe this Generally Recognized As Safe product.

Research Studies

I asked Dr. Lindemann why a number of outcome measures I am used to seeing in asthma studies were not included in some of the research reported with LungLaid.

She pointed out that FEV1 is not well correlated with asthma severity based on symptoms and rescue inhaler use. FDA has stated that “clinically meaningful improvements in lung function as measured by spirometry may not correlate well with improvements in asthma-related symptoms and their impact on a patient’s ability to perform daily activities” in a 2006 industry guidance document focused on patient-reported outcome measures. FEV1 measurement also does not improve assessment of asthma control.

Validated asthma-related quality of life (QOL) questionnaires measure those patient reported outcomes identified by physicians and patients that are most critical for assessment of the adequacy of asthma treatments to achieve asthma control: activity limitation, and symptoms (including sleep disturbance, wheezing, shortness of breath, cough, and chest tightness).

These are the same criteria recommended by the National Institutes of Health, National Asthma Education and Prevention Program for assessment by physicians of asthma control.

Since the frequency and severity of asthma symptoms cannot be determined objectively by physicians, it is vitally important that QOL is included as an outcome measure in clinical studies.

What Is Your Biggest Asthma Problem?

We want to help you get control of your asthma. I want to hear about your biggest asthma problem so that we can try to help you develop a solution or better understand how to help.
 You are probably not the only one with the problem. Take a few minutes describing your problem so we can develop a solution together.

Sources

  1. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
  2. Juniper et al. 2005. Respiratory Medicine 99:553–558
  3. Email interview with Julianne Lindemann, Senior Scientific Advisor at PanTheryx.
  4. U.S. Food and Drug Administration. Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition.

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