SUNDAY, Sept. 19 (HealthDay News) -- For asthma patients whose
condition is not controlled with standard inhaled steroids, the
addition of Spiriva -- a medication already approved for lung
disease -- appears to improve breathing, a new study finds.
However, the study authors and an outside expert stressed that
these are early findings and much longer, larger clinical trials
are needed.
Tiotropium bromide (Spiriva)) belongs to a class of drugs called
anticholinergics, which work by enlarging the airways to allow for
easier breathing. Currently, the U.S. Food and Drug Administration
has only approved the medication for use by patients with chronic
obstructive pulmonary disease (COPD), a chronic ailment that is a
combination of bronchitis and emphysema.
Treating asthma has never been a one-size-fits-all proposition,
so "having a new class of asthma medications could be potentially
important," said lead researcher Dr. Stephen P. Peters, a professor
of pulmonary, critical care, allergy, and immunologic medicine at
Wake Forest University, in Winston-Salem, NC.
"People are different. Some people will respond to some medications, some respond to others," he said.
The report, funded by the U.S. National Heart, Lung, and Blood
Institute, is published in the Sept. 19 online edition of the
New England Journal of Medicine. The journal is releasing the data early to coincide with its presentation Sunday at the European Respiratory Society meeting in Barcelona.
For the study, Peters' team tried three drug regimens on 210
asthmatics. These included: Spiriva plus an inhaled steroid; a
double dose of the inhaled steroid; and an inhaled steroid plus
Serevent, a long-acting beta agonist that relaxes the muscles in
the airway.
Patients stayed on each regiment for 14 weeks.
The researchers found that Spiriva plus an inhaled steroid was
more effective than giving a double dose of steroids in improving
breathing and controlling asthma for these tough-to-treat
patients.
In addition, the combination of an inhaled steroid and Spiriva
was not less effective than using an inhaled steroid plus Serevent,
they said.
That's important, Peters said, because there have been some
safety concerns raised about long-acting beta agonists. These drugs
carry a note on their labels warning of the possibility of severe
adverse events, including death, he noted.
The results need to be confirmed in a much larger pool of
patients, Peters said, and he noted that the patients were not
followed long enough to see if Spiriva was able to reduce the
severity of asthma attacks and hospitalizations.
In addition, Spiriva's safety profile among asthmatics still
needs to be studied, he said.
Because the drug is not yet FDA-approved for use in asthma,
Peters was reluctant to recommend it for that use. "My hope is that
in three to five years we will have the drug approved for asthma,"
he said.
Dr. Shirin Shafazand, an assistant professor of pulmonary,
critical care and sleep medicine at the University of Miami Miller
School of Medicine, said that "perhaps there is a role for Spiriva
in these poorly controlled asthmatics."
However, at this stage there is no definitive answer whether
Spiriva should or shouldn't be used in asthma, she said.
"This is a good foundation to design a trial where you would look at Spiriva plus steroids versus doubling the dose of steroids in a large number of asthmatics who are poorly controlled and then you follow them long-term," Shafazand said, but right now there is no data on long-term efficacy and safety.
More information
For more information on asthma, visit the
U.S. National Library of Medicine.