UW-Madison Launches H1N1 Study with Asthma Sufferers
H1N1 Influenza A (Swine Flu) Resources
Madison, Wisconsin - The University of Wisconsin School of Medicine and Public Health (SMPH) is one of just seven research centers conducting the first clinical trial in the nation to determine the dose of H1N1 vaccine necessary to give immunity to people with asthma.
The study is co-sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI, both part of the National Institutes of Health (NIH).
William Busse, MD, professor of medicine in the allergy and asthma section of SMPH and the principal investigator for the UW Asthma, Allergy and Pulmonary Clinical Research Center, says any type of flu can be dangerous for asthma sufferers because the virus infects the breathing tubes and lungs.
A 2004 study hinted that asthma sufferers who take high doses of inhaled or oral steroids may get less protection from the flu vaccine dose recommended for the general population.
Nationwide, 350 people with mild, moderate and severe asthma will be recruited for the study, which will compare two different dosages of H1N1 vaccine and look at how well study participants develop antibodies to the H1N1 virus. Researchers will also look at the differences between people with mild to moderate asthma and those with severe asthma.
Participants will be organized into two groups: those with mild or moderate asthma and those with severe asthma. Half of the participants in each group will be given a 15-microgram dose of vaccine; the other half of each group will get a 30-microgram dose.
The study will not involve a placebo. Three weeks after the first dose, study participants will get a second dose. The study also will collect safety data about the vaccine in people with asthma.
Busse says that finding the optimal dose that can safely be given to asthma patients is critical.
"A study during the spring H1N1 flu outbreak found that a majority of the patients hospitalized had underlying medical conditions like asthma," said Busse. "The data found that while asthma occurs in eight percent of the U.S. population, 32 percent of patients hospitalized during the flu outbreak had asthma."
Date Published: 10/21/2009