Temporary quadrupled glucocorticoid dose helps reduce severe asthma exacerbations, study finds

Forty-five percent of patients in a quadrupling group versus 52% of patients in a nonquadrupling group had a severe exacerbation in the year after randomization.

A personalized self-management strategy including temporary quadrupling of glucocorticoid dose helped decrease rates of severe asthma exacerbations, according to a recent study.

Researchers performed a pragmatic, unblinded, randomized trial in adults and adolescents who were taking inhaled glucocorticoids for asthma, with or without add-on therapy, and had had at least one asthma exacerbation in the previous 12 months. Patients were randomly assigned to a personal self-management plan that included the option of quadrupling the glucocorticoid dose when asthma control was beginning to deteriorate or to a personal self-management plan that instead instructed patients to continue inhaled glucocorticoids at their normal dose. The study's primary outcome over 12 months was time to first severe asthma exacerbation, which was defined as treatment with systemic glucocorticoids or an unscheduled consultation with a health care professional due to asthma. The study results were published online March 3 by the New England Journal of Medicine.

Overall, 1,922 patients 16 years of age or older were randomized (957 to the quadrupling group and 965 to the nonquadrupling group) and 1,871 were included in the primary analysis (933 in the quadrupling group and 938 in the nonquadrupling group). Most of the participants (81%) were recruited from primary care. Mean age of all participants was 57 years, and 68% were women. Four hundred twenty patients in the quadrupling group had a severe exacerbation in the year after randomization versus 484 patients in the nonquadrupling group (45% vs. 52%). The adjusted hazard ratio for time to first severe exacerbation was 0.81 (95% CI, 0.71 to 0.92; P=0.002). Hospitalization for asthma was the most common serious adverse event, occurring three times in the quadrupling group and 18 times in the nonquadrupling group, and was also included in the primary outcome analysis. Oral candidiasis and dysphonia were the most common nonserious adverse events (36 events in the quadrupling group and nine events in the nonquadrupling group).

The authors noted that their results could have been affected by the open-label nature of the trial but concluded that temporarily quadrupling the dose of inhaled corticosteroids when asthma control begins to deteriorate helps to decrease the number of severe asthma exacerbations. Fifteen patients in their trial needed to be provided with a self-management plan involving a quadrupled glucocorticoid dose to prevent one severe asthma exacerbation, the authors wrote, with a 95% CI for the number needed to treat of 9 to 43 patients. “Given the potential benefit with respect to preventing exacerbations and in view of the toxic effects of inhaled glucocorticoids and the biases that may have been introduced by the absence of blinding, individual practitioners, patients, and guideline committees will need to consider whether the magnitude of the reduction achieved is clinically meaningful,” they wrote.

In other asthma news, a case report published March 13 by Annals of Internal Medicine suggested that bronchial thermoplasty may be an effective treatment for severe asthmatic cough. Researchers in Japan used bronchial thermoplasty to treat all visible bronchi in a 34-year-old woman with asthma who had a 2.5-year history of chronic cough that had worsened despite treatment with high-dose inhaled corticosteroids, long-acting beta2-agonists, and leukotriene-receptor antagonists. Three procedures were administered at three-week intervals.

Cough improved immediately after the first procedure, and three months after the final procedure, frequency of cough, cough-related quality of life, and asthma control had all improved. The case authors concluded that bronchial thermoplasty should be considered in patients with severe asthmatic cough that has not responded to traditional therapies.