Potential New Option for Moderate or Severe Asthma

If you have asthma that's more than mild, you’re probably using a daily steroid inhaler for long-term control. But if that doesn't help your breathing, what's the next step? The National Asthma Education and Prevention Program recommends that your doctor take one of two actions: Double your corticosteroid dose or add a long-acting beta2 agonist like salmeterol (Serevent) or formoterol (Foradil) to your regular steroid routine.

The problem with doubling the dose of a steroid is that if you don't respond well enough to a low dose, you may not respond much better to a higher dose. Long-acting beta2 agonists tend to work well, but they have been shown to increase the risk of life-threatening asthma attacks. Clearly, neither of these options is ideal. Now, however, unexpected results from a study reported in the New England Journal of Medicine may point to a new option.

Surprising findings

The study, which was sponsored by the National Heart, Lung, and Blood Institute, included 210 adults with asthma that was poorly controlled by an inhaled steroid. Participants were randomly assigned to one of three treatments or a placebo group for 14 weeks:

After a short break, each participant moved on to a different group. A total of 174 people cycled through all three regimens. As expected, participants had fewer asthma symptoms and better lung function when following the Spiriva regimen than when following the double-dose steroid regimen. What was surprising, however, was that the Spiriva regimen was just as effective as the Serevent regimen.

Questions and concerns

Because this study lasted for only a short period, no one can say what long-term effects Spiriva might have on asthma. For example, this study didn't look at factors such as whether Spiriva reduced the risk of asthma attacks, hospitalizations for asthma, or steroid use. Longer studies involving more people are needed to answer those questions.

There was also some concern that Spiriva might increase the risk of stroke, heart attack and death. However, results from a large 2009 trial reported in the American Journal of Respiratory and Critical Care Medicine did not find a link. Another concern is that Spiriva, and other drugs in the same class, could mask underlying inflammation of the airways. Again, more study is needed to determine whether this is true.

Cost, too, is an important issue. Spiriva is more expensive than Serevent or beclomethasone (the steroid used in the New England Journal study): about $230 a month versus $180 and $80, respectively.

What it means for you

If you're not getting adequate relief by taking a low or medium dose of inhaled steroids, should you be taking Spiriva? Not necessarily. If your current regimen isn't adequately controlling your asthma, it's possible that your doctor will still suggest adding a long-acting beta2 agonist. Evidence suggests that life-threatening asthma attacks may be less likely to occur when these agents are used in conjunction with an inhaled steroid.

Your doctor may consider Spiriva as a second-line alternative. Although Spiriva has not been approved by the FDA for the treatment of asthma, doctors can prescribe it "off label" if they have reason to believe it will be safe and effective.

Other second-line options your doctor may consider adding include montelukast (Singulair) or another leukotriene modifier, theophylline, anti-IgE treatment in certain cases, or oral steroids. In general, however, and unlike Spiriva, these options are not as effective as adding a long-acting beta2 agonist, or they may have side effects or other drawbacks that make them less desirable alternatives.

The best way to determine what's right for you is to talk to your doctor about the risks and benefits of the currently available treatment options.

Publication Review By: Peter B. Terry, M.D., M.A.

Published: 14 Aug 2013

Last Modified: 14 Aug 2013