By Ves Dimov, MD
Allergist/Immunologist, Assistant Professor of Pediatrics & Medicine, University of Chicago
Editor, WAO Small Airways Working Group website
Posted 15 December 2011
Daily vs. Intermittent Budesonide in Preschool Children with Recurrent Wheezing: No Difference
Daily inhaled corticosteroids are recommended for young children at risk for asthma exacerbations and an exacerbation in the preceding year. However, concerns remain about effects on growth. This study published in the New England Journal of Medicine compared daily therapy with intermittent therapy with nebulized budesonide in 278 children aged 12 to 53 months. All of them had positive modified asthma predictive index (API), recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. They were randomly assigned to receive a budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during respiratory tract illness) or a daily regimen (0.5 mg nightly).
The daily regimen of budesonide 0.5 mg did not differ significantly from the intermittent regimen with in terms of exacerbations or adverse events.
The authors concluded that a daily low-dose regimen of budesonide 0.5 mg was not superior to an intermittent high-dose regimen (1 mg twice a day) in reducing asthma exacerbations. This is an important development especially considering that the mean exposure to budesonide was 104 mg less with the intermittent regimen.
Source: Zeiger RS, Mauger D, Bacharier LB, Guilbert TW, Martinez FD, Lemanske RF, Strunk RC et al. Daily or Intermittent Budesonide in Preschool Children with Recurrent Wheezing. New England Journal of Medicine 2011; 365(21):1990-2001, November 24.
Asthmatics who slept beneath the stream of cool air device for one year had improved quality of life and decreased airway inflammation
A randomized, double-blind, placebo-controlled trial evaluated whether environmental control with nocturnal temperature controlled laminar airflow (TLA) treatment could improve the quality of life of 312 patients aged 7–70 with inadequately controlled persistent atopic asthma in 19 European asthma clinics. TLA devices were installed in the bedrooms of patients to provide a stream of cool air above their heads.
There was a statistically significant difference in treatment response rate between active (76%) and placebo (61%) groups (p=0.02). There was also a difference between groups in fractional exhaled nitric oxide (FeNO) change of −7.1 ppb (p=0.03). Interestingly, the nocturnal temperature controlled laminar airflow (TLA) was associated with less increase in cat-specific IgE than placebo.
The study authors concluded that TLA improves quality of life, airway inflammation and systemic allergy in patients with persistent atopic asthma. Even if the benefits of TLA are confirmed in future trials, the expected relatively high cost of the device (Protexo) may be problematic. A similar device (Opragon) by the same Swedish company (Airsonett) is used to reduce surgical site infections. Neither device is available in the United States.
Source: Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A et al. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax November 2011, Online First [doi:10.1136/thoraxjnl-2011-200665]
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No dose-response relationship for fluticasone furoate in moderate/severe asthma: 200 mcg once daily worked as well as 800 mcg
Fluticasone furoate (FF) is a new inhaled corticosteroid with 24-hour activity. GlaxoSmithKline is developing FF as a once-daily asthma treatment in combination with the long-acting β2 agonist vilanterol trifenatate.
This 8-week multicentre, randomized, double-blind study included 627 adult patients with persistent moderate-to-severe asthma, who were symptomatic on medium-dose inhaled corticosteroid therapy. The study was sponsored by GlaxoSmithKline and company employees were among the co-authors.
The patients were randomized to placebo, FF 200, 400, 600 or 800 μg (once daily in the evening using a new dry powder inhaler), or fluticasone propionate 500 μg twice daily (via Diskus or Accuhaler).
Each inhaled steroid dose was superior to placebo for the primary endpoint (p<0.001) which was pre-dose evening forced expiratory volume in one second (FEV1).
There was no dose–response relationship across the FF doses studied. Peak expiratory flow improved in all groups. The incidence of oral candidiasis was higher with FF 800 μg than placebo; there was also a higher systemic exposure of FF at this highest dose level.
The study authors concluded that FF doses <800 μg have a favorable therapeutic index, and 200 μg is an appropriate dose in patients with moderate persistent asthma.
Source: Busse WW, Bleecker ER, Bateman ED, Lötvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax 2012;67(1):35-41 [doi:10.1136/thoraxjnl-2011-200308]
Posted 15 December 2011