KEYSTONE, COLO. — Optimal treatment of allergic rhinitis symptoms provides no added benefit in terms of improved control of coexistent asthma, Dr. Harold S. Nelson said at a meeting on allergy and respiratory disease sponsored by the National Jewish Medical and Research Center.
This conclusion, based on the negative findings of two large, well-conducted clinical trials, is a major disappointment, said Dr. Nelson, professor of medicine at the center as well as at the University of Colorado, Denver.
Several preliminary studies suggested that treating nasal symptoms might have a favorable effect on lower airway disease. These very small studies consistently showed that the use of intranasal corticosteroids in patients with allergic rhinitis and asthma resulted in improvement in bronchial hyperresponsiveness.
But then came the two definitive tests. Dr. Nelson was a coauthor of one—a 4-week, 92-site, double-blind, randomized clinical trial involving 863 patients with comorbid asthma and seasonal allergic rhinitis. All of the participants in the GlaxoSmithKline Inc.-sponsored study received open-label inhaled fluticasone propionate/salmeterol 100/50 mcg b.i.d. for their asthma, in addition to fluticasone propionate nasal spray, oral montelukast, or placebo for their allergic rhinitis. The addition of fluticasone nasal spray or montelukast significantly reduced nasal symptoms, compared with placebo, but it had no effect on asthma symptoms (Chest 2005;128:1910–20).
The other major double-blind multicenter trial, led by physicians at the Aarhus (Denmark) University, involved 262 patients with coexistent asthma and pollen-induced rhinitis. Beginning 2 weeks before the start of pollen season, they were randomized to 6 weeks of intranasal fluticasone propionate, inhaled fluticasone propionate, both, or dual placebos.
Only inhaled fluticasone significantly improved morning peak flow, methacholine responsiveness, and forced expiratory volume in 1 second, and quelled lower airway inflammation as reflected in blockage of the seasonal increase in sputum eosino- phils. And only intranasal fluticasone effectively controlled nasal symptoms (Allergy 2005;60:875–81).
Dr. Nelson noted as an aside that, in the Danish study, intranasal fluticasone essentially provided complete protection against nasal blockage, sneezing, and rhinorrhea during the pollen season, because treatment began 2 weeks before onset of the pollen season, which is the right way to do it. In clinical practice, intranasal corticosteroids are far less effective when started only after patients become symptomatic, he stressed.
Dr. Erwin W. Gelfand noted that the message of these and several other studies is very different from the prevailing theory of the last decade. “It seems like we're moving away from the notion of comorbid conditions—sinusitis, [gastroesophageal reflux disease], rhinitis—impacting asthma. A series of studies has come up showing that aggressive treatment of the comorbid condition has little impact on asthma control,” said Dr. Gelfand, chairman of the department of pediatrics at National Jewish Medical and Research Center and professor of pediatrics and immunology at the University of Colorado, Denver.
Dr. Nelson disclosed that he is a consultant to GlaxoSmithKline, Abbott Laboratories, APT Pharmaceuticals Inc., Curalogic A/S, Dey Laboratories, MediciNova Inc., Johnson and Johnson, Schering-Plough Corp., Dynavax Technologies Corp., Genentech Inc., and Novartis. Dr. Gelfand is a consultant to Teva Specialty Pharmaceuticals LLC, Novartis, Schering-Plough, and Altana Pharma U.S. Inc., and is on the Merck & Co. speakers bureau.
New data suggest that aggressive treatment of comorbiditieshas little impact on asthma control. DR. GELFAND