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Daily inhaled steroids for mild asthma?

The Problem

A 35-year-old male comes in for evaluation of dyspnea on exertion. He was diagnosed with exercise-induced asthma 7 years ago and now has chest tightness after 20 minutes of exercise. He has never used asthma medications and has never had nocturnal symptoms. His symptoms never begin at rest. Exercise-induced discomfort and shortness of breath now persist for up to an hour. Pulmonary function tests show a mild obstructive pattern at baseline with a forced expiratory volume in 1 second (FE[V.sub.1]) of 3.70 (75% predicted), FE[V.sub.1]/forced vital capacity of 62.8 (predicted > 71.0), and a methacholine challenge of 15%. Diffusion capacity of carbon monoxide and exercise oximetry are normal. You prescribe daily inhaled steroids. Several months later, he says he has improved with lifestyle modification and wants to stop the medication. Should you advise him to keep using it?

The Question

In patients with mild persistent asthma, are daily steroids more effective than symptom-based steroids for decreasing asthma exacerbations?

The Evidence

We went to PubMed ( and entered "asthma AND inhaled steroids," limiting the articles to randomized controlled trials.

Our Critique

National Institutes of Health/National Heart, Lung, and Blood Institute guidelines define mild persistent asthma as symptoms occurring more than twice per week but less than once per day, with exacerbations that affect activity, with FE[V.sub.1] or peak expiratory flow (PEF) of at least 80% of predicted values.

The investigators selected patients with mild persistent asthma who had a high degree of adherence; in the study, they had only 0.13 exacerbations per patient-year. Several putative biological makers for asthma severity were lower in the daily budesonide group, as was the number of symptom-free days, but these do not convincingly justify the expense of daily therapy. The NIH/NHLBI guidelines recommend a daily medication such as inhaled steroids for mild persistent asthma. But such therapy is expensive, and patients often feel it is unnecessary. The excellent evidence from this study challenges the traditional paradigm.

Patient Preferences & Clinical Decision

You contact the patient by phone and discuss the situation with him. You establish a plan for intermittent dosing of inhaled steroids and review how he should self-monitor. You will see him back in your office in 6 months.

H.A. Boushey, et al., with the National Heart, Lung, and Blood Institute's Asthma Clinical Research Network. Daily versus as-needed corticosteroids for mild persistent asthma (N. Engl. J. Med. 2005;352:1519-28).

* Design and Setting: Randomized, double-blind, six-site trial with a run-in period used to select patients who were at least 70% adherent.

* Subjects: Patients had physician-diagnosed asthma, were aged 18-65 years, had FE[V.sub.1] at least 70% of predicted value, and had an increase in FE[V.sub.1] of at least 12% and at least 200 mL after inhalation of albuterol or a fall in FE[V.sub.1] of at least 20% after inhaling a concentration of methacholine of less than 16 mg/mL.

* Intervention: Patients were instructed on symptom-based management using open-label budesonide (800 mcg twice daily) for 10 days or prednisone (0.5 mg/kg per day) for 5 days if asthma worsened. After the run-in period, patients received 10-14 days of intense combined therapy (PICT) to eliminate easily reversed causes of airflow obstruction: 0.5 mg/kg of prednisone, 800 mcg of budesonide twice daily, 20 mg of zafirlukast twice daily, and albuterol as needed. Patients were then randomized to one of three treatments: 200 mcg of budesonide (inhaler) + placebo tablets, 20 mg of zafirlukast twice daily + placebo inhaler, or placebo tablets + placebo inhaler (intermittent treatment).

* Outcomes: The primary outcome was change from baseline in 2-week average morning PEF. Other outcomes included changes from baseline in FE[V.sub.1] before bronchodilator use, morning PEF during PICT, and FE[V.sub.1] after PICT. Patients completed questionnaires on asthma control and quality of life.

* Results: Of 225 patients randomized, 199 completed the study. Adherence to study medications exceeded 90% and was similar for all groups. Change in morning PEF from the final 2 weeks of the run-in period to the final 2 weeks of the year of treatment did not differ significantly among groups. Use of open-label budesonide was no greater in the intermittent-treatment group than in the groups taking daily budesonide or zafirlukast. The prebronchodilator FE[V.sub.1] increased more in the budesonide group than in the other two groups (P = .005) without a significant difference in the postbronchodilator FE[V.sub.1] (P = .29). Patients treated with budesonide had greater improvements in the percentage of eosinophils in the sputum. The proportion of patients who had one or more exacerbations did not differ significantly among the groups. Improvements in the asthma control score and number of symptom-free days were significantly greater with budesonide treatment than with either zafirlukast or intermittent treatment, and a greater number of symptom-free days over a 2-week period was seen with budesonide (4.0 days, vs. 2.9 days with intermittent treatment).


DR. EBBERT and DR. TANGALOS are with the Mayo Clinic in Rochester, Minn. To respond to this column or suggest topics for consideration, write to Dr. Ebbert and Dr. Tangalos at our editorial offices or
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Author:Ebbert, Jon O.; Tangalos, Eric G.
Publication:Internal Medicine News
Geographic Code:1USA
Date:Jun 15, 2005
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