MONDAY, Dec. 20 (HealthDay News) -- Denufosol, an ion channel regulator, may improve lung function in cystic fibrosis patients with normal to mildly impaired lung function by impairing the formation of sticky mucus, according to research published online Dec. 17 in the American Journal of Respiratory and Critical Care Medicine.
To evaluate the safety and efficacy of denufosol, Frank J. Accurso, M.D., of the University of Colorado Denver in Aurora, and colleagues randomized 352 cystic fibrosis patients aged 5 years or older who had normal to mildly impaired lung function to inhaled denufosol 60 mg or placebo three times daily over 24 weeks.
From baseline to the week 24 end point, the researchers found that the mean change in expiratory volume at one second was 0.048 L for denufosol and 0.003 L for placebo (P = 0.047). The drug was well tolerated and adverse events were similar in both groups, with denufosol recipients experiencing fewer incidents of headache, sinusitis, and runny nose. There were no significant differences between the groups for secondary end points such as exacerbation rate and other measures of lung function.
"Denufosol improved lung function relative to placebo in cystic fibrosis patients with normal to mildly impaired lung function," the authors write.
The study was funded by Inspire Pharmaceuticals. Several authors disclosed financial ties to Inspire and other pharmaceutical and/or medical device companies.